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: 2026-03-16
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
2026-03-16
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=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=10 Participants
|
3 Participants
n=50 Participants
|
4 Participants
n=108 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=10 Participants
|
39 Participants
n=50 Participants
|
85 Participants
n=108 Participants
|
|
Age, Continuous
|
80.0 years
STANDARD_DEVIATION 7.41 • n=10 Participants
|
76.6 years
STANDARD_DEVIATION 6.95 • n=50 Participants
|
78.4 years
STANDARD_DEVIATION 7.36 • n=108 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=10 Participants
|
16 Participants
n=50 Participants
|
33 Participants
n=108 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=10 Participants
|
26 Participants
n=50 Participants
|
56 Participants
n=108 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=10 Participants
|
1 Participants
n=50 Participants
|
1 Participants
n=108 Participants
|
|
Race (NIH/OMB)
White
|
43 Participants
n=10 Participants
|
41 Participants
n=50 Participants
|
84 Participants
n=108 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=108 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=10 Participants
|
0 Participants
n=50 Participants
|
4 Participants
n=108 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=10 Participants
|
42 participants
n=50 Participants
|
89 participants
n=108 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 |
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.
|
|---|---|---|
|
Number of Participants With Main Access-related Bleeding and Vascular Complications
|
47 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Periprocedural through hospital discharge, an average of 1.5 daysSecondary endpoints will be the number of participants with periprocedural complications, acute vessel closure, embolization, vessel perforation, the procedural characteristics (duration, fluoroscopy time, contrast volume), length of hospital stay, and cost of hospitalization.
Outcome measures
| 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.
|
|---|---|---|
|
The Number of Participants With Periprocedural Complications, What the Procedural Characteristics Are, and Hospitalization.
|
47 Participants
|
42 Participants
|
Adverse Events
Dual Perclose Proglide
Serious events: 1 serious events
Other events: 1 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.
|
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