Optimal Heart Failure Therapy for Aortic Valve Stenosis

Phase-Based Progress Estimates
Minneapolis Heart Institute, Minneapolis, MNAortic Valve StenosisOptimal Heart Failure Therapy - Biological
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Aortic Valve Stenosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 2 Secondary · Reporting Duration: 12 month

12 month
-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
12 months
All-Cause Death
Change in KCCQ relative to baseline
Disabling Stroke
Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Active Control

Experimental Treatment

300 Total Participants · 2 Treatment Groups

Primary Treatment: Optimal Heart Failure Therapy · No Placebo Group · N/A

TAVR (with SAPIEN 3 THV) and OHFTExperimental Group · 2 Interventions: Optimal Heart Failure Therapy, SAPIEN 3 THV · Intervention Types: Biological, Device
ActiveComparator Group · 1 Intervention: Optimal Heart Failure Therapy · Intervention Types: Biological

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month

Who is running the clinical trial?

AvaniaIndustry Sponsor
31 Previous Clinical Trials
8,232 Total Patients Enrolled
Cardiovascular Research Foundation, New YorkLead Sponsor
18 Previous Clinical Trials
21,074 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

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your body is suitable for a specific type of heart valve replacement called transfemoral TAVR using either the SAPIEN 3 or SAPIEN 3 Ultra THV.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.