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

Baylor Research Institute92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Transcatheter Aortic Valve Replacement Closure Technique

Interventions

Double Perclose ProglideDEVICE

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

Single Perclose Proglide plus AngiosealDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Baylor Scott & White The Heart Hospital - Plano

Plano, Texas, United States

Outcomes

Primary Outcomes

Number of Participants With 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

Secondary Outcomes

The Number of Participants With Periprocedural Complications, What the Procedural Characteristics Are, and Hospitalization.

Secondary 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.

Time frame: Periprocedural through hospital discharge, an average of 1.5 days

Data from ClinicalTrials.gov

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