Closure Techniques for Transcatheter Aortic Valve Replacement

(TAVI-CLOSE Trial)

Overseen By Bonnie Ostergren

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Baylor Research Institute

Disqualifiers: Non-femoral access, Previous femoral repair, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Periprocedural

90 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 who are scheduled for a heart valve replacement through the thigh artery and can consent to participate. It's not open to those with past thigh artery issues, non-thigh surgery plans, involvement in conflicting studies, or inability to provide consent.

Inclusion Criteria

I am scheduled for a heart valve replacement through my leg.

Able to provide written informed consent prior to study participation

Exclusion Criteria

I have had a pseudoaneurysm in my thigh artery before.

Non-femoral access

Currently enrolled in another research study that has not granted permission to dual-enroll.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Transfemoral Transcatheter Aortic Valve Replacement and receive femoral access closure using either dual Perclose Proglide or single Perclose Proglide and Angioseal

Periprocedural

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of clinical changes, re-interventions, and peripheral pulse evaluation

4 weeks

1 visit (in-person) at 30 days

Treatment Details

Interventions

• Double Perclose Proglide
• Single Perclose Proglide plus Angioseal

Trial Overview The study compares two methods of closing the thigh artery after heart valve replacement: using two ProGlide devices versus one ProGlide plus an Angioseal device. Participants will be randomly assigned to either method in this safety-focused trial.

Participant Groups

Group I: Dual Perclose Proglide Active Control 1 Intervention

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

Group II: Single Perclose Proglide plus Angioseal Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials

210

Recruited

205,000+