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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2025-10-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Transcatheter Aortic Valve Replacement Closure Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Dual Perclose Proglide

Upon completion of valve replacement, this cohort will be closed using dual Perclose Proglide devices.

Group Type ACTIVE_COMPARATOR

Double Perclose Proglide

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Single Perclose Proglide plus Angioseal

Intervention Type DEVICE

Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.

Interventions

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Double Perclose Proglide

Upon completion of valve replacement, closure will proceed using two Perclose Proglide devices.

Intervention Type DEVICE

Single Perclose Proglide plus Angioseal

Upon completion of valve replacement, closure will proceed using one Perclose Proglide device plus one Angioseal device.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years old
* Planned to undergo transcatheter aortic valve replacement via femoral access
* Able to provide written informed consent prior to study participation

Exclusion Criteria

* Non-femoral access
* Previous repair or intervention of the common femoral artery
* Previous pseudoaneurysm of the common femoral artery
* Children below 18 years, prisoners, and patients who are unable to provide consent are excluded.
* In another research study that has not granted permission to dual-enroll.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No