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Transcatheter Heart Valve

TAVR for Heart Failure

N/A
Waitlist Available
Research Sponsored by Cardiovascular Research Foundation, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Heart Failure with NYHA class ≥ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month
Awards & highlights

Study Summary

This trial is testing whether TAVR is safe and effective for heart failure patients with moderate aortic stenosis, as compared to those who receive no treatment.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include risks associated with heart valve replacement like bleeding, blood vessel complications, irregular heartbeat, stroke, infection risk from the procedure, and potential reactions to anesthesia or contrast media.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My heart condition limits my physical activities.
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I have been on stable heart failure treatment for at least 1 month.
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My body is suitable for a specific heart valve replacement through my thigh.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-Cause Death
Change in KCCQ relative to baseline
Disabling Stroke
+1 more
Secondary outcome measures
-All-cause death within EATI
MACCE defined as the composite of all-cause death, all stroke, and hospitalizations for heart failure or symptomatic aortic valve disease or clinically significant worsening of heart failure within EATI. Hierarchical occurrence within EATI of

Trial Design

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 Location

Who is running the clinical trial?

Cardiovascular Research Foundation, New YorkLead Sponsor
24 Previous Clinical Trials
26,569 Total Patients Enrolled
AvaniaIndustry Sponsor
41 Previous Clinical Trials
8,396 Total Patients Enrolled
Cardialysis BVIndustry Sponsor
8 Previous Clinical Trials
2,541 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
231 Patients Enrolled for Aortic Valve Stenosis

Media Library

SAPIEN 3 THV (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02661451 — N/A
Aortic Valve Stenosis Research Study Groups: TAVR (with SAPIEN 3 THV) and OHFT, OHFT
Aortic Valve Stenosis Clinical Trial 2023: SAPIEN 3 THV Highlights & Side Effects. Trial Name: NCT02661451 — N/A
SAPIEN 3 THV (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02661451 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate tally of participants in this trial?

"To properly execute this study, Avania must find 300 volunteers meeting the inclusion criteria. The sponsor has decided to run clinical operations out of UCLA Medical Center in Los Angeles, Wisconsin and Advocate Aurora- St. Lukes in Milwaukee, Maine."

Answered by AI

What is the geographic reach of this clinical experiment?

"To date, 47 patients have been enrolled in this trial at various locations such as UCLA Medical Center (Los Angeles), Advocate Aurora-St. Lukes (Milwaukee) and Maine Medical Centre (Portland). In addition to these sites, there are 44 other enrolment points across the US."

Answered by AI

Are there still openings in this experiment that participants can take advantage of?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical trial is now selecting participants and was first made public on September 1st 2016. The study requires 300 individuals from 47 different sites across the US."

Answered by AI
~21 spots leftby Mar 2025