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

Not Applicable

Recruiting

• Conditions: Transcatheter Aortic Valve Replacement; Closure Technique

• Registration Number: NCT06983938
• Lead Sponsor: Baylor Research Institute

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-02-12
• Status Verified: 2025-05
• Study First Submitted: 2025-05-06
• Study First Submitted QC: 2025-05-14
• Last Update Submitted: 2025-05-14
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Main access-related bleeding and vascular complications	Periprocedural	Primary endpoint collected will be composite endpoint of main access-related bleeding ≥Type 2 and main access related major vascular complication- VARC (Valve Academic Research Consortium) 3 Criteria.

Secondary Outcome Measures

Name	Time	Method
Periprocedural complications, procedural characteristics, hospitalization	Periprocedural through hospital discharge	Secondary endpoints will be periprocedural complications, acute vessel closure, embolization, and vessel perforation, procedural characteristics (duration, fluoroscopy time, contrast volume), length of hospital stay, and cost of hospitalization.

Trial Locations

Locations (1)

Baylor Scott & White The Heart Hospital - Plano; 🇺🇸 Plano, Texas, United States