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New heart device aims to ease pressure in failing hearts

NCT ID NCT03523416

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This early study tests a device that creates a small opening between the upper chambers of the heart to relieve pressure in people with symptomatic heart failure. The study includes 71 participants and focuses on safety and whether the device works as intended. It is not a cure but aims to control the disease and improve symptoms.

What this could mean

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

Active substance
Transcatheter Atrial Shunt System (a device that creates a small passage between the upper chambers of the heart)
What this could lead to
If it works, this device could offer a new way to manage heart failure symptoms and reduce hospital stays.
What could go wrong
This is an early feasibility study with only 71 people, so it's too soon to know if it's safe or effective. There are risks of heart, brain, or kidney 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

71 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Nov 2028

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.

Inclusion Criteria: * Symptomatic Heart Failure (HF): * NYHA class II with a history of \> II; III; or ambulatory IV AND * ≥ 1 HF hospital admission; or treatment with IV or oral diuresis within 12 months; OR an NT-pro BNP value \> 150 pg./ml in normal sinus rhythm, \> 450 pg./ml in atrial fibrillation, or a BNP value \> 50 pg./ml in normal sinus rhythm, \> 150 pg./ml in atrial fibrillation within the past 6 months prior to study entry. * On stable Guideline Directed Medical Therapy (GDMT) for heart failure * At rest: elevated LAP (or PCWP) of \> 15 mmHg and LAP (or PCWP) exceeds right atrial pressure (RAP) by \> 5 mmHg AND/OR supine ergometer exercise, elevated LA (or PCWP) pressure of \> 25 mmHg and LA (or PCWP) exceeds right atrial pressure (RAP) by \> 10 mmHg * Left Ventricular Ejection Fraction (LVEF) ≤ 40% * Pulmonary Vascular Resistance (PVR) \< 4.0 WU Exclusion Criteria: * Severe HF: * Stage D, non-ambulatory NYHA Class IV, transplant list * If BMI \< 30, Cardiac index \< 2.0 L/min/m2 * If BMI ≥ 30, cardiac index \< 1.8 L/min/m2 * Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm * LVEF \< 20% * Valve disease: MR \> 3+ or \> moderate MS, TR \> 2+, AR \> 2+ or \> moderate AS * MI or therapeutic invasive cardiac procedure \< 3 months * TIA, stroke, CRT implanted \< 6 months * RV dysfunction \> mild by TTE OR TAPSE \< 1.2 OR RV size ≥ LV size by TTE, OR right ventricular fractional area change (RVFAC) ≤ 25% * Dialysis OR renal dysfunction (S-CR \> 2.5 mg/dl OR eGFR \< 25 ml/min/1.73m2) * 6MWT \< 50m OR \> 600m * Active endocarditis or infection \< 3 months * Mean Right Atrial Pressure (mRAP) \> 15 mmHg at rest * Body Mass Index (BMI) ≥ 45 kg/m2

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Conditions

The condition(s) this trial relates to.

heart failure systolic 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

    Minneapolis, Minnesota, 55407, United States

  • Atrium Health

    Charlotte, North Carolina, 28203, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • St. Vincent Medical Group

    Indianapolis, Indiana, 46260, United States

  • Swedish Medical Center

    Seattle, Washington, 98122, United States

  • The Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • The Ohio State University Medical Center

    Columbus, Ohio, 43210, United States

  • UC San Diego Health

    La Jolla, California, 92037, United States

  • University California San Francisco

    San Francisco, California, 94143, United States

  • University of Florida Health - Jacksonville

    Jacksonville, Florida, 32209, United States

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