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 (TAVI-CLOSE)

Baylor Scott and White Health (BSWH)

Status: Completed

Conditions: Transcatheter Aortic Valve Replacement; Closure Technique

Treatments: Device: Single Perclose Proglide plus Angioseal; Device: Double Perclose Proglide

Study type: Interventional

Funder types: Other

Identifiers

NCT06983938

024-458

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Dual Perclose Proglide

Active Comparator group

Description:

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

Treatment:

Device: Double Perclose Proglide

Single Perclose Proglide plus Angioseal

Active Comparator group

Description:

Upon completion of valve replacement, this cohort will be closed using a single Perclose Proglide device and single Angioseal device.

Treatment:

Device: Single Perclose Proglide plus Angioseal