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Heart shunt shows promise for easing heart failure symptoms

NCT ID NCT05686317

Disease control Sponsor: Edwards Lifesciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called the Edwards APTURE shunt, which is implanted in the heart to create a small opening that lowers pressure. The goal is to see if it can improve symptoms and quality of life for 100 people with a certain type of heart failure. Half of the participants get the real shunt, and half get a sham procedure, so the results will be compared fairly.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Edwards APTURE transcatheter shunt system (a device implanted to create a small passage between heart chambers to reduce pressure)
What this could lead to
If it works, this could offer a new device-based option to improve symptoms and quality of life for people with heart failure who have limited treatment choices.
What could go wrong
This is a relatively small, early-stage trial (100 people) and the device is compared to a sham procedure, so results may not be definitive. There are also risks from the implant procedure, such as serious heart or blood vessel complications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2023

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: • Symptomatic heart failure 1. A primary diagnosis of HFmrEF or HFpEF (LVEF \> 40%), and 2. NYHA class II to ambulatory NYHA class IV (IVa), and 3. Documentation of at least one of the following from the date of initial informed consent or date of enrollment: i. Within the prior 12 months, EITHER: * HF hospital admission (with HF as the primary or secondary diagnosis) * Treatment with intravenous (IV) or intensification of oral diuretics for HF ii. Within the prior 6 months, EITHER: * BNP value \> 35 pg/ml in normal sinus rhythm (NSR) or paroxysmal atrial fibrillation (AF) * BNP \> 125 pg/ml for permanent or long-term persistent AF * NT-proBNP \> 125 pg/ml in NSR or paroxysmal AF * NT-proBNP \> 375 pg/ml for permanent or long-term persistent AF d. There is objective evidence of cardiogenic pulmonary congestion based on hemodynamic criteria obtained by right heart catheterization (RHC) at exercise, and confirmed by hemodynamics core lab as: As measured at end-expiration, pulmonary capillary wedge pressure (PCWP) at ≥ 20 Watts exercise (PCWP ≥ 20W) is elevated to ≥ 25 mmHg and exceeds \[the corresponding\] right atrial pressure (RAP) by ≥ 8 mmHg • In the judgment of the treating physician and the Central Screening Committee the patient is on GDMT for HFpEF/HFmrEF for \>30 days prior to screening and baseline assessments, that is expected to be maintained without change for 6 months. Key Exclusion Criteria: * Severe heart failure defined as one or more of the below: 1. ACC/AHA/ESC Stage D HF, non-ambulatory NYHA Class IV HF 2. If Body Mass Index (BMI) \< 30, cardiac index \< 2.0 L/min/m2 3. If BMI ≥ 30, cardiac index \< 1.8 L/min/m2 4. Inotropic infusion (continuous or intermittent) within the past 6 months 5. Patient is on the cardiac transplant waiting list 6. Prior diagnosis of HF with reduced ejection fraction (HFrEF), including patients with improvement in LVEF to \> 40% * Valve disease: 1. Degenerative mitral regurgitation \> moderate 2. Functional or secondary mitral valve regurgitation defined as grade \> moderate 3. Mitral stenosis \> mild 4. Primary or secondary tricuspid valve regurgitation defined as grade \> moderate 5. Aortic valve disease defined as aortic regurgitation grade \> moderate or aortic stenosis \> moderate * More than mild right ventricular (RV) dysfunction as determined by the echo core lab, taking into account the following available parameters: 1. Tricuspid annular plane systolic excursion (TAPSE) \<1.4 cm, or 2. RV size ≥ LV size 3. Right ventricular ejection fraction (RVEF) \< 35%; or 4. Imaging or clinical evidence of congestive hepatopathy * Mean right atrial pressure (mRAP) \> 15 mmHg at rest * Pulmonary vascular resistance (PVR) ≥ 5.0 WU * BMI ≥ 45 * Myocardial infarction (MI) and/or any therapeutic invasive, non-valvular cardiovascular procedure within past 3 months or current indication for coronary revascularization * Stroke, transient ischemic attack (TIA), deep vein thrombosis (DVT) or pulmonary embolus within the past 6 months * Renal insufficiency as determined by creatinine (sCr) level \> 2.5 mg/dL or estimated glomerular filtration rate (eGFR) \< 25ml/min/1.73 m2 by CKD-Epi equation; or currently requiring dialysis * Performance of the six-minute walk test (6MWT) with a distance \< 50m OR \> 450m * Active endocarditis or infection requiring intravenous antibiotics within 3 months

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Conditions

The condition(s) this trial relates to.

diastolic heart failure heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

Contacts and locations

Locations

  • Abbott Northwestern Hospital

    Minneapolis, Minnesota, 55407, United States

  • Ascension Illinois Heart and Vascular Medical Group

    Elk Grove, Illinois, 60007, United States

  • Herz- und Diabeteszentrum NRW - Bad Oeynhausen

    Bad Oeynhausen, 32545, Germany

  • Herzzentrum Dresden GmbH Universitätsklinik für Innere Medizin und Kardiologie

    Dresden, 01307, Germany

  • Herzzentrum Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Instituto do Coracao da Universidade de Sao Paulo

    São Paulo, 05403-900, Brazil

  • Johannes Gutenberg Universitaet Mainz

    Mainz, 55131, Germany

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic

    Rochester, Minnesota, 55902, United States

  • Medical University of South Carolina Charleston

    Charleston, South Carolina, 29425', United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Oklahoma Heart Institute

    Tulsa, Oklahoma, 74104, United States

  • Oregon Health and Science University

    Oregon City, Oregon, 97239, United States

  • Scripps Health

    La Jolla, California, 92037, United States

  • St. Francis Hospital & Heart Center

    Roslyn, New York, 11576, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

  • The Ottawa Hospital

    Ottawa, Canada, Canada

  • University of California Irvine

    Irvine, California, 92868, United States

  • University of California San Diego

    La Jolla, California, 92027, United States

  • University of California San Francisco

    San Francisco, California, 94143, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Universitätsklinikum Heidelberg Medizinische Klinik

    Heidelberg, 69120, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

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