Trial Outcomes & Findings for Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement (NCT NCT03432494)
NCT ID: NCT03432494
Last Updated: 2023-03-14
Results Overview
Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
TERMINATED
NA
12 participants
1 minute following procedure discharge (Exit from the catheterization laboratory)
2023-03-14
Participant Flow
Participant milestones
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Overall Study
STARTED
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12
|
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Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Overall Study
Death
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1
|
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Overall Study
Noncompliance
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1
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Baseline Characteristics
Transmural Systems Transcaval Closure Device for Transcaval Access Ports During Transcatheter Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
|
Region of Enrollment
United States
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12 participants
n=99 Participants
|
|
Ineligible for transfemoral access
|
12 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)Number of participants with technical success of delivery of the transcaval closure device (TCD) All of the following must be present for technical success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system 5. Adjunctive balloon aortic tamponade is permissible and consistent with technical success
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants With Technical Success of Delivery of the Transcaval Closure Device (TCD)
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 minute following procedure discharge (Exit from the catheterization laboratory)Number of Participants With Technical Closure Success of Delivery of the Transcaval Closure Device (TCD). This secondary endpoint is a composite of the primary endpoint and hemostasis of the transcaval aortic access site. All of the following must be present for Closure Success: 1. Alive 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success 5. Complete occlusion of the aortocaval fistula on the completion aortogram.
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants With Closure Success of the Transcaval Closure Device (TCD)
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9 Participants
|
SECONDARY outcome
Timeframe: 30 days and 12 MonthsPopulation: Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts.
A key performance endpoint is the number of participants who experienced device success of the transcaval closure device (TCD). All of the following must be present for device success: 1. Alive or Death unrelated to transcaval access or TAVR 2. Original intended TCD in place 3. No additional surgical or interventional procedures related to access or the device after exit from the cath lab Intended performance of the TCD, including all of: 1. Structural Performance: No migration, embolization, detachment, fracture, hemolysis, or endarteritis related to the TCD 2. Hemodynamic performance: No abdominal aortic obstruction caused by the TCD implant 3. Absence of para-device complications (large retroperitoneal hematoma, pseudoaneurysm, distal thromboembolism, or pulmonary thromboembolism)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
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Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)
30 Days
|
12 Participants
|
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Number of Participants Who Experienced Device Success of the Transcaval Closure Device (TCD)
12 Months
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Intention-to-treat (ITT) analysis
Number of participants that experienced safety endpoint of procedural success following transcaval closure device (TCD) at day 30. All of the following must be present for procedural success: 1. Device success 2. No device-related Serious Adverse Events, defined as VARC-2 life-threatening bleeding, major vascular or cardiac complications related to the TCD requiring unplanned reintervention or surgery (such as covered stent implantation at the transcaval access site)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants That Experienced Procedural Success
|
12 Participants
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SECONDARY outcome
Timeframe: During procedure, procedure may last from 2 to 4 hoursNumber of participants requiring covered stent implantation as a normal provisional part of the procedure assessed during the procedure.
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants Requiring Covered Stent Implantation as a Normal Provisional Part of the Procedure
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0 Participants
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SECONDARY outcome
Timeframe: During procedure, procedure may last from 2 to 4 hoursNumber of participants with covered stent implantation at the transcaval closure device (TCD) implantation site
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
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Number of Participants With Covered Stent Implantation at the Transcaval Closure Device Implantation Site
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: intention-to-treat (ITT) analysis
Number of Participants final acute aorto-caval fistula score at procedure completion. Scoring is defined as: Type 0=occlusion, Type 1=patent fistula, Type 2=cruci-form fistula pattern, Type 3=extravasation. A score of 0 is associated with complete occlusion at the transcaval closure device (TCD) site while a higher score is associated with incomplete occlusion at the TCD site.
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants Final Acute Aorto-caval Fistula Score
Type 3
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0 Participants
|
|
Number of Participants Final Acute Aorto-caval Fistula Score
Type 0
|
9 Participants
|
|
Number of Participants Final Acute Aorto-caval Fistula Score
Type 1
|
1 Participants
|
|
Number of Participants Final Acute Aorto-caval Fistula Score
Type 2
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: intention-to-treat (ITT) analysis
Participants who experienced Minor or Major modified Valve Academic Research Consortium-2 (VARC-2) vascular complications. Major is defined as: Aortic dissection or aortic rupture; Access site-related arterial or venous injury THAT RESULTS IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage; severe access site vascular complication Minor is defined as: Access site-related arterial or venous injury THAT DOES NOT RESULT IN death, hemodynamic compromise, life-threatening, extensive; or major bleeding, visceral ischemia, neurological impairment; Distal embolization treated with embolectomy and/or thrombectomy not resulting in amputation or irreversible end-organ damage; Any unplanned endovascular stenting or unplanned surgical intervention not meeting the criteria for a major vascular complication; Vascular repair
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Major : Unrelated to Transcaval Closure Device
|
0 participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Major : At Least Possibly Related to Transcaval Closure Device
|
0 participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Minor Unrelated to Transcaval Closure Device : Unrelated to Transcaval Closure Device
|
1 participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Vascular Complications
Minor Unrelated to Transcaval Closure Device: At Least Possibly Related to Transcaval Closure Device
|
1 participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: intention-to-treat (ITT) analysis
Number of Participants Who Experienced Major or Life-threatening Modified Valve Academic Research Consortium-2 (VARC-2) bleeding complications at 30 days Major defined as: Corrected drop in the hemoglobin of \>=3.0 g/dl AND does not meet criteria of life-threatening or extensive bleeding; Requiring transfusion of \>=3 U of whole blood or packed RBCs AND does not meet criteria of life-threatening or extensive bleeding. Life-threatening defined as: Intracranial requiring surgery or intervention; Intraspinal requiring surgery or intervention; Intraocular requiring surgery or intervention; Pericardial requiring surgery or intervention; Intramuscular with compartment syndrome; Bleeding causing hypovolemic shock or hypotension or requiring significant doses of vasopressors or surgery
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Major : Unrelated to Transcaval Closure Device
|
1 Participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Life-threatening : Unrelated to Transcaval Closure Device
|
0 Participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Life-threatening : At least Possibly Related to Transcaval Closure Device
|
0 Participants
|
|
Number of Participants Who Experienced Modified Valve Academic Research Consortium-2 Bleeding Complications
Major : At least Possibly Related to Transcaval Closure Device
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30Population: intention-to-treat (ITT) analysis
Number of Participants Who Experienced Major Adverse Cardiovascular Events (MACE) Major adverse cardiovascular events (MACE), defined as VARC-2 Early Safety composite: No mortality, stroke, life-threatening bleeding, acute kidney injury (AKI) stage 2+, major vascular complication, and valve-related complication.
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Stroke : Unrelated to Transcaval Closure Device
|
2 Participants
|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Stroke : At least possibly related to Transcaval Closure Device
|
0 Participants
|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Myocardial Infraction : Unrelated to Transcaval Closure Device
|
1 Participants
|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Myocardial Infraction : At least possibly related to Transcaval Closure Device
|
0 Participants
|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Acute Kidney Injury (Stage II or III) : Unrelated to Transcaval Closure Device
|
0 Participants
|
|
Number of Participants Who Experienced Major Adverse Cardiovascular Events
Acute Kidney Injury (Stage II or III) : At least possibly related to Transcaval Closure Device
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 Days and 12 MonthsPopulation: Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For 12 months analysis, one participant died and one participant taken off study due to noncompliance.
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD). All of the following must be present for Closure Success: 1. Alive or Death unrelated to transcaval access or TAVR 2. Successful delivery of the TCD, and retrieval of the TCD delivery system 3. Deployment and correct positioning of a single intended TCD. Repositioning and recapture of the device, if needed, is not classified as failure. 4. No additional unplanned or emergency surgery or re-intervention related to the TCD or delivery system. Adjunctive balloon aortic tamponade is permissible and consistent with technical success 5. Complete occlusion of the aortocaval fistula on the completion aortogram.
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)
30 Days
|
12 Participants
|
|
Number of Participants With Closure Success of Delivery of the Transcaval Closure Device (TCD)
12 Months
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 DaysAll-cause mortality, as categorized by cardiovascular vs non-cardiovascular, peri- vs non-periprocedural, regardless of attribution to Transcaval Closure Device (TCD)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
All-Cause Mortality
Cardiovascular Deaths : Unrelated to Transcaval Closure Device
|
0 Participants
|
|
All-Cause Mortality
Cardiovascular Deaths : At least possibly related to Transcaval Closure Device
|
0 Participants
|
|
All-Cause Mortality
Non-Cardiovascular Deaths : Unrelated to Transcaval Closure Device
|
1 Participants
|
|
All-Cause Mortality
Non-Cardiovascular Deaths : At least possibly related to Transcaval Closure Device
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30, 12 monthsPopulation: Data will be analyzed using principles both of (1) intention-to-treat, defined as attempting or initiating transcaval crossing procedures, and (2) as-treated, defined as completing transcaval closure attempts. For month 12, one participant died and one participant taken off study due to noncompliance.
Number of participants with aorto-caval fistula patency at each timepoint, assessed combining completion angiography and arterial-phase follow-up Computed tomography (CT).
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography
Day 30
|
12 Participants
|
|
Number of Participants With Aorto-caval Fistula Patency Assessed by Angiography and Arterial-phase Follow-up Computed Tomography
12 Months
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: intention-to-treat (ITT) analysis
Number of participants who experienced acute kidney injury (AKI) stage 2 or 3 using the Valve Academic Research Consortium (VARC). AKI using the VARC definition: Stage 2: increase in serum creatinine to 200-300% (2.0-3.0 times increase compared to baseline) or increase of \>0.3 mg/dl (\>26.4 mmol/L) but \<4.0 mg/dl (\<354 mmol/L) Stage 3: increase in serum creatinine to ≥300% (\>3 times increase compared to baseline) or serum creatinine of ≥4.0 mg/dl (≥354 mmol/L), with acute increase of ≥0.5 mg/dl (44 mmol/L)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3
Acute Kidney Injury, Stage II
|
0 Participants
|
|
Number of Participants Who Experienced Acute Kidney Injury Stage 2 or 3
Acute Kidney Injury, Stage III
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 30, 12 MonthsPopulation: Intention-to-treat (ITT) analysis. One participant died on post-procedure day 15 from respiratory failure attributed to exacerbation of previously unrecognized fibrotic pulmonary disease, adjudicated as noncardiovascular mortality and unrelated to transcaval access or TAVR. One participant at month 12 was taken off study due to non-compliance.
Number of participants that experience freedom from infection related to the Transcaval Closure Device (TCD) at each time point
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
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|---|---|
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Number of Participants That Are Free From Infection Related to the Transcaval Closure Device
Day 30
|
12 Participants
|
|
Number of Participants That Are Free From Infection Related to the Transcaval Closure Device
12 months
|
10 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: intention-to-treat (ITT) analysis
Number of participants that experience Thrombocytopenia as defined as \< 50,000 and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants That Experience Thrombocytopenia and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
|
0 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: intention-to-treat (ITT) analysis
Number of participants who experience hemolysis and is attributable to residual aorto-caval fistula or the Transcaval Closure Device (TCD)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants Who Experience Hemolysis and is Attributable to Residual Aorto-caval Fistula or the Transcaval Closure Device
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 30Population: intention-to-treat (ITT) analysis
Participant cumulative Computed tomography (CT) analysis of device. As defined by: Device position; Device integrity; Aortocaval tract pseudo-aneurysm; Aortic pseudoaneurysm; Retroperitoneal hematoma grade (stranding {=absent and not evidence of overt bleeding;} small; moderate; larger); Intracaval mass or thrombus; Aortic dissection and inferred relatedness to TCD (adjacent to access port) or procedure (remote to access port)
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Participant Cumulative Computed Tomography Analysis of Device
Migration
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Erosion
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Retroperitoneal hematoma
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Aortic pseudoaneurysm
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Aortocaval tract pseudo-aneurysm
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Intracaval mass or thrombus
|
0 Participants
|
|
Participant Cumulative Computed Tomography Analysis of Device
Aortic dissection
|
0 Participants
|
SECONDARY outcome
Timeframe: EnrollmentPopulation: One participant is under 65 years of age and not included.
Outcomes of subjects greater than 65 years (i.e. eligible for Medicare based on age), to determine generalizability to the Medicare population
Outcome measures
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 Participants
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Number of Participants Enrolled Greater Than 65 Years
|
11 Participants
|
Adverse Events
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
Serious adverse events
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 participants at risk
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Atrioventricular block complete
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Cardiac Chest pain
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Heart failure
|
16.7%
2/12 • Number of events 2 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Mobitz (type) II atrioventricular block
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Myocardial infarction
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Infections and infestations
Bronchial infection
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Infections and infestations
C. Difficile infection
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Cardiac troponin I increased
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Creatinine increased
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Nervous system disorders
Dysarthria
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Nervous system disorders
Stroke
|
16.7%
2/12 • Number of events 3 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Nervous system disorders
Transient ischemic attacks
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Arterial thromboembolism
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Labile blood pressure
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
Other adverse events
| Measure |
Transcaval Access and Closure With the Transcaval Closure Device (TCD) Test Article
n=12 participants at risk
All participants undergo transcaval access for transcatheter aortic valve replacement (TAVR) followed by implantation of the transcaval closure device (TCD).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
12/12 • Number of events 12 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Blood and lymphatic system disorders
Hemolysis
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
58.3%
7/12 • Number of events 7 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Aortic valve disease
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Mild AVR paravalvular leak
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Moderate PV aortic regurgitation
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Cardiac Chest pain
|
16.7%
2/12 • Number of events 2 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Conduction disorder
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Heart failure
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Cardiac disorders
Right ventricular dysfunction
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Gastrointestinal disorders
Diarrhea
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
General disorders
Edema limbs
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
General disorders
Fever
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
1/12 • Number of events 2 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Left femoral hematoma
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Right groin oozing
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Small right groin hematoma
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Injury, poisoning and procedural complications
Head laceration with fall
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Aspartate aminotransferase increased
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Blood lactate dehydrogenase increased
|
75.0%
9/12 • Number of events 9 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Cardiac troponin I increased
|
83.3%
10/12 • Number of events 10 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Creatinine increased
|
25.0%
3/12 • Number of events 5 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Haptoglobin decreased
|
16.7%
2/12 • Number of events 2 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Elevated BNP
|
25.0%
3/12 • Number of events 3 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Elevated BUN
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Elevated Haptoglobin
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Investigations
Platelet count decreased
|
50.0%
6/12 • Number of events 6 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
33.3%
4/12 • Number of events 4 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Psychiatric disorders
Delirium
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Skin and subcutaneous tissue disorders
In-situ squamous cell carcinoma lesion on right dorsal forearm.
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Arterial thromboembolism
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Hypertension
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
|
Vascular disorders
Superficial thrombophlebitis
|
8.3%
1/12 • Number of events 1 • 12 months
Adverse events and adverse device effects will captured up to day 30 follow up, then only serious adverse events (SAE), serious adverse device effects (SADE), unanticipated de-vice effects (UADE) and unanticipated problems (UP) will be reported for remainder of study (12 month follow up).
|
Additional Information
Dr. Robert Lederman, Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place