TAVR for Heart Failure

Not currently recruiting at 52 trial locations

Overseen By Hiral Patel, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cardiovascular Research Foundation, New York

Must be taking: Heart failure therapy

Must not be taking: Clopidogrel, aspirin, anticoagulants

Disqualifiers: Severe lung disease, kidney disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of a treatment called TAVR, a heart procedure, for patients with heart failure and moderate aortic stenosis (a narrowed heart valve). Researchers will compare TAVR combined with heart failure therapy to heart failure therapy alone. The study seeks participants who experience heart failure symptoms affecting daily life and have maintained stable heart treatment for at least a month. It is suitable for individuals with moderate aortic stenosis who can undergo a procedure involving the insertion of a new valve through the leg artery. As an unphased trial, this study provides patients the opportunity to contribute to important research that could enhance future treatment options.

Do I need to stop my current medications for the TAVR trial?

The trial does not specify if you need to stop your current medications, but it requires that you are on stable heart failure therapy for at least one month before joining. It's best to discuss your medications with the trial team to ensure they are appropriate for your condition.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the SAPIEN 3 Transcatheter Aortic Valve Replacement (TAVR) is safe for patients. Previous studies have linked TAVR to a 68% lower risk of hospitalization for heart failure compared to monitoring the condition, allowing patients to stay healthier and out of the hospital more often.

The SAPIEN 3 valve used in TAVR has demonstrated long-lasting performance, continuing to function well without needing replacement. There is no significant difference in valve failure rates, indicating its dependability.

Past patients have not reported serious issues related to the valve or the procedure, suggesting that the treatment is well-tolerated. Overall, evidence supports TAVR with the SAPIEN 3 as a safe option for treating heart problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about TAVR with the SAPIEN 3 THV for heart failure because it offers a minimally invasive alternative to open-heart surgery. Unlike traditional treatments that may involve more invasive procedures, TAVR uses a catheter-based approach to replace a damaged heart valve, potentially reducing recovery time and risks associated with surgery. This method is particularly beneficial for patients who are not ideal candidates for surgery due to age or other health concerns. Additionally, pairing TAVR with Optimal Heart Failure Therapy (OHFT) could enhance overall heart function, offering a comprehensive approach to managing heart failure.

What evidence suggests that TAVR with SAPIEN 3 THV could be effective for heart failure?

Research has shown that the SAPIEN 3 Transcatheter Aortic Valve Replacement (TAVR), which participants in this trial may receive, can significantly benefit patients with heart failure. Studies found that TAVR reduced the risk of hospital visits for heart failure by 68% over five years compared to those who were only monitored. As a result, patients who received TAVR spent less time in the hospital. Additionally, the SAPIEN 3 valve has proven effective without causing major issues with the valve's structure or function over time. These findings suggest that TAVR with the SAPIEN 3 valve could be a promising treatment for heart failure patients with moderate narrowing of the heart valve. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

My heart's right ventricle is not working well.

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

You have other conditions that make it difficult for you to understand and follow the study requirements.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37407110/

Outcomes of SAPIEN 3 Transcatheter Aortic Valve ... There were no differences in structural valve deterioration-related stage 2 and 3 hemodynamic valve deterioration or bioprosthetic valve failure ...

2. treatheartvalvefailure.com treatheartvalvefailure.com/hcp/about-tavr-by-edwards/patient-outcomes

Patient Outcomes | Heart Valve Failure HCP Prompt TAVR resulted in a 68% lower risk of hospitalization for heart failure through 5 years vs clinical surveillance (5.3% vs 12%).

3. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.116.022797

One-Year Clinical Outcomes With SAPIEN 3 Transcatheter ... Important exclusion criteria included congenital bicuspid disease, ejection fraction <20%, renal failure, severe mitral or aortic regurgitation, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02675114

Study Details | NCT02675114 | PARTNER 3 Trial: Safety ... ... (Valve-related or Procedure-related and Including Heart Failure), Number of ... Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/sapien-3-ultra-balloon-expandable-transcatheter-aortic-valve-in-hospital-and-30-day-results-from-the-multicentre-s3u-registry

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra ... heart failure. Acute heart failure · Chronic heart failure. Peripheral ... Transcatheter treatment for tricuspid valve disease. Praz F et al. free. 116.75 ...

6. businesswire.com businesswire.com/news/home/20251027951599/en/Edwards-SAPIEN-3-TAVR-Delivers-Proven-Long-term-Benefits-and-Valve-Performance-New-Data-Presented-at-TCT-2025

Edwards SAPIEN 3 TAVR Delivers Proven Long-term ... Valve durability indicators remained excellent and stable over time, with no difference in bioprosthetic valve failure (6.9% vs. 7.3%) or ...