Trial Outcomes & Findings for This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement (NCT NCT06983938)
NCT ID: NCT06983938
Last Updated: 2026-06-25
Results Overview
Primary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
92 participants
Primary outcome timeframe
Periprocedural through hospital discharge, an average of 1.5 days
Results posted on
2026-06-25
Participant Flow
Participant milestones
| Measure |
Dual Perclose Proglide
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
Single Perclose Proglide Plus Angioseal
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
45
|
|
Overall Study
COMPLETED
|
47
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
This Study Will Evaluate the Safety and Potential Complications of Dual ProGlide vs Single ProGlide and Angioseal for Common Femoral Arteriotomy Closure Following Transcatheter Aortic Valve Replacement
Baseline characteristics by cohort
| Measure |
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
85 Participants
n=40 Participants
|
|
Age, Continuous
|
80.0 years
STANDARD_DEVIATION 7.41 • n=20 Participants
|
76.6 years
STANDARD_DEVIATION 6.95 • n=20 Participants
|
78.4 years
STANDARD_DEVIATION 7.36 • n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
33 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=20 Participants
|
26 Participants
n=20 Participants
|
56 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=20 Participants
|
41 Participants
n=20 Participants
|
84 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=20 Participants
|
42 participants
n=20 Participants
|
89 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Periprocedural through hospital discharge, an average of 1.5 daysPrimary endpoint collected will be the number of participants with the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Main Access-related Bleeding and Vascular Complications
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Periprocedural through hospital discharge, an average of 1.5 daysA secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Periprocedural Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Periprocedural, around 1.5 hoursTotal procedure duration from procedure start to completion.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Procedural Total Duration
|
31 Minutes
Interval 25.0 to 38.0
|
32 Minutes
Interval 27.0 to 39.0
|
SECONDARY outcome
Timeframe: Periprocedural, around 1.5 hoursTotal fluoroscopy time will be measured from procedure start to completion.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Fluoroscopy Time
|
8.3 Minutes
Interval 6.5 to 10.4
|
10 Minutes
Interval 6.5 to 13.1
|
SECONDARY outcome
Timeframe: Periprocedural, about 1.5 hoursTotal contrast volume will be measured from the start of the procedure until completion.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Contrast Volume
|
40 milliliters
Interval 34.0 to 50.0
|
37 milliliters
Interval 30.0 to 53.0
|
SECONDARY outcome
Timeframe: From patient arrival until discharge, about 1.5 daysThe length of the hospital stay will be collected.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Length of Hospital Stay
|
1.1 Days
Interval 1.0 to 1.2
|
1.1 Days
Interval 1.0 to 1.2
|
SECONDARY outcome
Timeframe: Patient arrival to discharge, about 1.5 daysThe cost of the hospital stay will be collected.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Cost of Hospital Stay
|
42419.4 Dollars
Standard Deviation 4923.06
|
41932.9 Dollars
Standard Deviation 3091.06
|
SECONDARY outcome
Timeframe: Periprocedural, about 1.5 hoursThe number of participants with minor vascular complications will be collected
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Minor Vascular Complications
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Periprocedural, about 1.5 hoursThe number of participants with the need for a secondary closure device will be collected.
Outcome measures
| Measure |
Single Perclose Proglide Plus Angioseal
n=42 Participants
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
Dual Perclose Proglide
n=47 Participants
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
|---|---|---|
|
Need for Secondary Closure Device
|
0 Participants
|
0 Participants
|
Adverse Events
Dual Perclose Proglide
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Single Perclose Proglide Plus Angioseal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dual Perclose Proglide
n=47 participants at risk
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
Single Perclose Proglide Plus Angioseal
n=42 participants at risk
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure with interstital lung disease and viral infection
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
0.00%
0/42 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
Other adverse events
| Measure |
Dual Perclose Proglide
n=47 participants at risk
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Double Perclose Proglide: Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
|
Single Perclose Proglide Plus Angioseal
n=42 participants at risk
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Single Perclose Proglide plus Angioseal: Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
|
|---|---|---|
|
Gastrointestinal disorders
Acute Cholecystitis
|
2.1%
1/47 • Number of events 1 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
0.00%
0/42 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
|
Respiratory, thoracic and mediastinal disorders
Acute chronic hypoxic respiratory failure
|
2.1%
1/47 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
0.00%
0/42 • Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.
|
Additional Information
Bonnie Ostergren
Baylor Scott & White Research Institute
Phone: 469-814-4181
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place