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Aortic Valve StenosisNCT02661451

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

A study testing SAPIEN 3 THV and Optimal Heart Failure Therapy in people with Aortic Valve Stenosis, run by Cardiovascular Research Foundation, New York at 51 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Valve Stenosis
What is being tested?
SAPIEN 3 THV and Optimal Heart Failure Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
178 participants
Where
51 sitesin 3 countries
Study dates
Sep 2016to Feb 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All candidates for this study must meet all of the following 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.
  • Note: Patients are expected to be on appropriate pharmacologic therapy and if indicated CRT for heart failure. (12, 13) Patients with aortic stenosis may not be able to tolerate maximal doses of heart failure medications and no specific guidelines exist for the medical treatment of heart failure in the setting of aortic stenosis. It is expected that the heart failure PI will review the medical therapy and confirm that it is appropriate for the patient's condition.
  • 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.
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  • Note: Typically such cases will demonstrate,
  • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg at rest and aortic valve area (AVA) > 1.0 cm2 and ≤1.5 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) at rest
  • OR
  • Mean trans-aortic gradient (MG) ≥ 20 mmHg and < 40 mmHg and aortic valve area (AVA) ≤1.0 cm2 at rest AND MG < 40 mmHg and aortic valve area (AVA)
  • •>1.0 cm2 (or AVA < 1.0 cm2 but indexed AVA > 0.6 cm2) with low dose dobutamine stress echo (DSE).
  • In atypical cases (for example mean gradient is below 20 mmHg but valve area is consistent with moderate AS, the final eligibility determination in regards to diagnosis of moderate AS will be made by the echocardiographic core lab.
  • 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)

Who cannot join

  • Candidates are excluded from the study if any of the following conditions are present:
  • LVEF < 20% or persistent need for intravenous inotropic support
  • Hospitalization for acute decompensated HF within 2 weeks prior to randomization
  • Cardiac resynchronization therapy (CRT) device implantation within 1 month prior to randomization
  • Coronary artery revascularization (PCI or CABG) within 1 month prior to randomization
  • In need and suitable for revascularization per heart team consensus
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  • Severe aortic and/or mitral regurgitation
  • Congenital unicuspid or congenital bicuspid aortic valve
  • Concomitant non-aortic valvular disease with a formal indication for valve surgery per established guidelines (ESC/ACC/AHA)
  • Previous aortic valve replacement (mechanical or bioprosthetic)
  • Severe RV dysfunction
  • Previous stroke with permanent disability (modified Rankin score ≥ 2)
  • Severe lung disease as indicated by FEV1 <30% predicted or need for chronic daytime supplemental oxygen therapy
  • Severe chronic kidney disease: glomerular filtration rate (GFR) < 30 mL/min by MDRD or need for renal replacement therapy
  • Gastrointestinal (GI) bleeding within the past 3 months
  • Liver cirrhosis Child-Pugh C
  • Active systemic infection, including active endocarditis
  • Unwilling to accept blood transfusion
  • Evidence of intracardiac mass, thrombus or vegetation
  • Absence of minimum amount of aortic valve calcification necessary for TAVR with the SAPIEN 3 or SAPIEN 3 Ultra THV
  • Hypersensitivity or contraindication to clopidogrel, aspirin, or to oral anticoagulation if indicated (e.g. subject in atrial fibrillation)
  • Sensitivity to contrast media which cannot be adequately pre-medicated
  • Women of child-bearing potential
  • Clinical signs of dementia
  • Other medical, social, or psychological conditions that precludes appropriate consent and follow-up
  • Life expectancy < 2 years due to cancer or other non-cardiac chronic diseases
  • Unwillingness to undergo follow-up investigations
  • Currently participating in an investigational drug or another device trial that has not reached its primary endpoint (excluding registries)

Trial locations and contacts

51 sites in 3 countries.

51 sites in 3 countries

United States46 sites

  • Seton Medical Center Austin

    Austin, Texas, 78705

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Chandler Regional Medical Center

    Chandler, Arizona, 85224

  • Advocate Christ Hospital

    Chicago, Illinois, 60453

  • Northwestern University

    Chicago, Illinois, 60611

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • Evanston Hospital/NorthShore Univ. Health System

    Evanston, Illinois, 60210

  • UCSD/Sulpizio Cardiovascular Center

    La Jolla, California, 92037

  • University of Southern California - Los Angeles

    Los Angeles, California, 90033

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • University of Miami

    Miami, Florida, 33136

  • Oklahoma Heart Hospital

    Milwaukee, Wisconsin, 53211

  • Advocate Aurora- St. Lukes

    Milwaukee, Wisconsin, 53215

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Minneapolis Heart Institute

    Minneapolis, Minnesota

  • Morristown Memorial

    Morristown, New Jersey, 07962

  • IHC Health Services, Inc. dba Intermountain Medical Center

    Murray, Utah, 84107

  • Vanderbilt Heart and Vascular

    Nashville, Tennessee, 37203

  • Yale University

    New Haven, Connecticut, 06520

  • NYU Langone Medical Center

    New York, New York, 10016

  • Columbia University Medical Center/New York Presbyterian Hospital

    New York, New York, 10032

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • St. Joseph Hospital

    Orange, California, 92868

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine, 04102

  • Oregon Health Science University (OHSU)

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02904

  • Virginia Commonwealth University (VCU)

    Richmond, Virginia, 23298

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Beaumont Hospital

    Royal Oak, Michigan, 48072

  • Ascension St. Mary's Hospital

    Saginaw, Michigan, 48601

  • HealthEast Medical Research Institute

    Saint Paul, Minnesota, 55102

  • UCSF

    San Francisco, California, 94143

  • Swedish Medical Center

    Seattle, Washington, 98125

  • Washington University in St. Louis

    St Louis, Missouri, 63110

  • Carle Foundation Hospital

    Urbana, Illinois, 61801

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Cleveland Clinic Florida

    Weston, Florida, 33331

  • PinnacleHealth Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

  • WellSpan York Hospital

    York, Pennsylvania, 17405

Other trials in United States

Netherlands4 sites

  • Leiden University Medical Center

    Leiden

  • Erasmus Medical Center

    Rotterdam

  • University Medical Center Utrecht

    Utrecht, TH, 3584CX

  • Isala Clinics

    Zwolle

Other trials in Netherlands

Canada1 site

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure: A Randomized Trial (TAVR UNLOAD)

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.

Being tested
SAPIEN 3 THV, Optimal Heart Failure Therapy
Keywords
Valve
Medical subject headings
Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAPIEN 3 THVDevice

  • Optimal Heart Failure TherapyBiological

Study groups in NCT02661451
Study groupRoleWhat they receive
TAVR (with SAPIEN 3 THV) and OHFTExperimentalTranscatheter heart valve and Optimal Heart Failure Therapy
Receives: Device: SAPIEN 3 THV; Biological: Optimal Heart Failure Therapy
OHFTActive comparatorOptimal Heart Failure Therapy
Receives: Biological: Optimal Heart Failure Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-Cause Death

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

    Measured: 12 months

  2. Disabling Stroke

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

    Measured: 12 months

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

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

    Measured: 12 months

  4. Change in KCCQ relative to baseline

    Hierarchical occurrence within efficacy assessment time interval (EATI) of:

    Measured: 12 months

Secondary outcomes (2)

  1. 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:

    1. All-cause death
    2. Disabling stroke
    3. Hospitalizations related to heart failure, symptomatic aortic valve disease or non-disabling stroke or clinically significant worsening of heart failure (heart failure event)

    Measured: 12 month

  2. -All-cause death within EATI

    -All-cause death within EATI

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2016 (estimated)
  2. Study startSep 2016
  3. Primary completion28 Feb 2023
  4. Study completionFeb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
178 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02661451
Sponsor's protocol ID
TAVR Unload
Status last verified
Nov 2024
First submitted
15 Jan 2016
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
Yes

Publications

  • Esquitin KA, Khalique OK, Liu Q, Kodali SK, Marcoff L, Nazif TM, George I, Vahl TP, Leon MB, Hahn RT. Accuracy of the Single Cycle Length Method for Calculation of Aortic Effective Orifice Area in Irregular Heart Rhythms. J Am Soc Echocardiogr. 2019 Mar;32(3):344-350. doi: 10.1016/j.echo.2018.11.018. Epub 2019 Jan 28.

    PubMed 30704832

Questions about this trial

What is this clinical trial studying?

A study testing SAPIEN 3 THV and Optimal Heart Failure Therapy in people with Aortic Valve Stenosis, run by Cardiovascular Research Foundation, New York at 51 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, Netherlands, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-Cause Death (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02661451, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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