TAVR for Heart Failure

Recruiting at 50 trial locations

Overseen By Hiral Patel, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cardiovascular Research Foundation, New York

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine the safety and efficacy of transcatheter aortic valve replacement (TAVR) via a transfemoral approach in HF patients with moderate AS as compared with OHFT.

Eligibility Criteria

This trial is for adults over 18 with advanced heart failure and moderate aortic valve stenosis, who've been on stable heart failure therapy for at least a month. They must have an ejection fraction under 50% but not below 20%, and can't be in critical condition or have severe other diseases.

Inclusion Criteria

You have been diagnosed with moderate aortic stenosis (AS) by a specialized medical imaging center.

Your heart's pumping ability at rest is less than 50%.

I am 18 years old or older.

Exclusion Criteria

My heart's right ventricle is not working well.

I am allergic or cannot take clopidogrel, aspirin, or blood thinners if needed.

I am a woman who could become pregnant.

Treatment Details

Interventions

• SAPIEN 3 THV (Transcatheter Heart Valve)

Trial Overview The study tests if using the SAPIEN 3 THV device to replace the aortic valve through the leg vein is safe and works better than just optimal heart failure therapy alone in improving patients' conditions.

Participant Groups

Group I: TAVR (with SAPIEN 3 THV) and OHFT Experimental Treatment 2 Interventions

Transcatheter heart valve and Optimal Heart Failure Therapy

Group II: OHFT Active Control 1 Intervention

Optimal Heart Failure Therapy

Who Is Running the Clinical Trial?

Cardiovascular Research Foundation, New York

Lead Sponsor

Trials

28

Recruited

27,800+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Cardialysis BV

Industry Sponsor

Trials

9

Recruited

2,700+