An interventional study of Double Perclose Proglide and Single Perclose Proglide plus Angioseal in Transcatheter Aortic Valve Replacement and Closure Technique, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Baylor Research Institute · Not applicable, Interventional, and Other
This prospective, randomized, parallel, single-center, open-label, non-inferiority 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.
This is a prospective, randomized, parallel, open-label, single-center, non-inferiority study.
Approximately 90 patients undergoing Transcatheter Aortic Valve Replacement with femoral access will be randomized in a 1:1 fashion to receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal for closure.
The primary end point of this study is the composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication. Secondary end points include periprocedural complications (such as acute vessel closure, leg embolization and perforation), procedural characteristics (total duration, fluoroscopy time, contrast volume, length of hospital stay), and cost of hospitalization. A routine follow-up visit assessment will be performed at 30 days in the valve clinic and the assessment will include: any clinical change, re-interventions, and peripheral pulse evaluation.
Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.
Device: Double Perclose Proglide
Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.
Device: Single Perclose Proglide plus Angioseal
Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.
Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.
Main Access-related Bleeding and Vascular Complications
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.
Time frame: Periprocedural through hospital discharge, an average of 1.5 days
Periprocedural Complications
A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection.
Time frame: Periprocedural through hospital discharge, an average of 1.5 days
Procedural Total Duration
Total procedure duration from procedure start to completion.
Time frame: Periprocedural, around 1.5 hours
Fluoroscopy Time
Total fluoroscopy time will be measured from procedure start to completion.
Time frame: Periprocedural, around 1.5 hours
Contrast Volume
Total contrast volume will be measured from the start of the procedure until completion.
Time frame: Periprocedural, about 1.5 hours
Length of Hospital Stay
The length of the hospital stay will be collected.
Time frame: From patient arrival until discharge, about 1.5 days
Cost of Hospital Stay
The cost of the hospital stay will be collected.
Time frame: Patient arrival to discharge, about 1.5 days
Minor Vascular Complications
The number of participants with minor vascular complications will be collected
Time frame: Periprocedural, about 1.5 hours
Need for Secondary Closure Device
The number of participants with the need for a secondary closure device will be collected.
Time frame: Periprocedural, about 1.5 hours
| Milestone | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Started | 47 | 45 |
| Completed | 47 | 42 |
| Not completed | 0 | 3 |
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.
| Participants | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Main Access-related Bleeding and Vascular Complications | 1 | 3 |
A secondary endpoint will be the number of participants with periprocedural complications including acute vessel closure, leg embolization, or vessel perforation/dissection.
| Participants | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Periprocedural Complications | 0 | 0 |
Total procedure duration from procedure start to completion.
| Minutes | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Procedural Total Duration | 32 (27 to 39) | 31 (25 to 38) |
Total fluoroscopy time will be measured from procedure start to completion.
| Minutes | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Fluoroscopy Time | 10 (6.5 to 13.1) | 8.3 (6.5 to 10.4) |
Total contrast volume will be measured from the start of the procedure until completion.
| milliliters | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Contrast Volume | 37 (30 to 53) | 40 (34 to 50) |
The length of the hospital stay will be collected.
| Days | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Length of Hospital Stay | 1.1 (1.0 to 1.2) | 1.1 (1.0 to 1.2) |
The cost of the hospital stay will be collected.
| Dollars | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Cost of Hospital Stay | 41932.9 ± 3091.06 | 42419.4 ± 4923.06 |
The number of participants with minor vascular complications will be collected
| Participants | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Minor Vascular Complications | 0 | 0 |
The number of participants with the need for a secondary closure device will be collected.
| Participants | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Need for Secondary Closure Device | 0 | 0 |
Collected over Adverse events were collected from the start of the procedure procedure until 30-days after the procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dual Perclose Proglide | 1/47 (2.1%) | 1/47 (2.1%) | 2/47 (4.3%) |
| Single Perclose Proglide Plus Angioseal | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Event | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Respiratory Failure with interstital lung disease and viral infectionRespiratory, thoracic and mediastinal disorders | 1/47 | 0/42 |
| Event | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal |
|---|---|---|
| Acute CholecystitisGastrointestinal disorders | 1/47 | 0/42 |
| Acute chronic hypoxic respiratory failureRespiratory, thoracic and mediastinal disorders | 1/47 | — |
| Age, Categorical(Participants) | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 3 | 4 |
| >=65 years | 46 | 39 | 85 |
| Age, Continuous(years) | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal | Total |
|---|---|---|---|
| Mean | 80.0 ± 7.41 | 76.6 ± 6.95 | 78.4 ± 7.36 |
| Sex: Female, Male(Participants) | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal | Total |
|---|---|---|---|
| Female | 17 | 16 | 33 |
| Male | 30 | 26 | 56 |
| Race (NIH/OMB)(Participants) | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 43 | 41 | 84 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Region of Enrollment(participants) | Dual Perclose Proglide | Single Perclose Proglide Plus Angioseal | Total |
|---|---|---|---|
| United States | 47 | 42 | 89 |
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Baylor Research Institute