Active — Not RecruitingNot Applicable

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

United States, Canada, Netherlands178 participantsStarted 2016-09

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 years
. Heart Failure with NYHA class ≥ 2
. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization.
. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) \>1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS is suspected when the an AVA \> 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA\<1.0 cm2 but with an indexed AVA of \>0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients with AVA \>1.5 cm2 but with indexed AVA\<0.9 cm2/m2 on either rest of DSE are also eligible.
. Left ventricular (LV) ejection fraction (EF) \< 50% at rest
. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
. Able to provide independent informed consent (i.e., not requiring a legally authorized representative)

Exclusion criteria

. LVEF \< 20% or persistent need for intravenous inotropic support
. Hospitalization for acute decompensated HF within 2 weeks prior to randomization

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

All-Cause Death

Timeframe: 12 months

Disabling Stroke

Timeframe: 12 months

Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).

Timeframe: 12 months

Change in KCCQ relative to baseline

Timeframe: 12 months

Trial details

NCT IDNCT02661451

SponsorCardiovascular Research Foundation, New York

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Aortic Valve Stenosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 years
. Heart Failure with NYHA class ≥ 2
. Under appropriate and stable guideline-directed HF therapy for a minimum of 1 month prior to randomization.
. Moderate AS confirmed by the echo core lab. Moderate AS is defined as an aortic valve area (AVA) \>1.0 cm2 and ≤1.5 cm2 on rest echo or if ≤1.0 cm2 at rest and low-flow AS is suspected when the an AVA \> 1.0 cm2 with low dose dobutamine stress echo (DSE). Patients with AVA\<1.0 cm2 but with an indexed AVA of \>0.6 cm2/m2 on either rest or DSE are also eligible. Similarly, patients with AVA \>1.5 cm2 but with indexed AVA\<0.9 cm2/m2 on either rest of DSE are also eligible.
. Left ventricular (LV) ejection fraction (EF) \< 50% at rest
. Anatomically suitable for transfemoral TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
. Able to provide independent informed consent (i.e., not requiring a legally authorized representative)

Exclusion criteria

. LVEF \< 20% or persistent need for intravenous inotropic support
. Hospitalization for acute decompensated HF within 2 weeks prior to randomization

What they're measuring

All-Cause Death

Timeframe: 12 months

Disabling Stroke

Timeframe: 12 months

Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke -or - Clinically significant worsening of heart failure (heart failure hospitalization equivalent).

Timeframe: 12 months

Change in KCCQ relative to baseline

Timeframe: 12 months