TAVR for Heart Failure
Recruiting at 50 trial locations
OB
BS
HP
Overseen ByHiral Patel, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Cardiovascular Research Foundation, New York
Must be taking: Heart failure therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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%.
My heart condition limits my physical activities.
See 3 more
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.
See 23 more
Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive transcatheter aortic valve replacement (TAVR) via a transfemoral approach or Optimal Heart Failure Therapy
12 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
12 months
Treatment Details
Interventions
- SAPIEN 3 THV
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
2Treatment groups
Experimental Treatment
Active Control
Group I: TAVR (with SAPIEN 3 THV) and OHFTExperimental Treatment2 Interventions
Transcatheter heart valve and Optimal Heart Failure Therapy
Group II: OHFTActive Control1 Intervention
Optimal Heart Failure Therapy
Find a Clinic Near You
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+
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