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New heart shunt device could ease heart failure symptoms

NCT ID NCT04000607

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study is testing a device called the APTURE shunt, which is implanted in the heart to create a small passage that may help relieve pressure. It involves 45 people with symptomatic heart failure who are already on standard medications. The goal is to see if the device is safe and can improve symptoms and reduce the need for hospital care.

What this could mean

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

Active substance
APTURE transcatheter shunt system (a device implanted in the heart to create a small passage between chambers)
What this could lead to
If it works, this device could offer a new way to relieve pressure in the heart and improve symptoms for people with heart failure, potentially reducing hospital stays.
What could go wrong
This is an early exploratory study with only 45 participants, so results may not apply to everyone. There are risks from the implant procedure, including 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

45 people

The number who actually took part.

Started

Jul 2019

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 HF: * NYHA II w/ history of \> II; III; or ambulatory IV AND * ≥1 HF hospitalization OR treatment with IV or oral diuresis within 12 months OR Elevated NT-proBNP 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 GDMT for HF * Left Ventricular Ejection Fraction (LVEF) ≤ 40% as determined by site cardiologist * Hemodynamic criteria o At rest: Elevated LAP (or PCWP) \> 15 mmHg AND LAP \> RAP + 5 mmHg AND/OR supine ergometer exercise: elevated LAP (or PCWP) \> 25 mmHg AND LAP \> RAP + 10 mmHg * Pulmonary Vascular Resistance (PVR) \< 5.0 WU as determined by site cardiologist Exclusion Criteria * Severe HF: * NYHA IV, stage D, non-ambulatory, transplant list * Cardiac index ≤ 1.5 L/min/m2 * Left Ventricular End-Diastolic Diameter (LVEDD) \> 8 cm * LVEF \<20% * Valve disease * MR \>3+ or \> moderate MS, TR \>3+ (severe on 5-point scale), 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 \> 220 micromol/L OR e-GFR \< 25ml/min/1.73 m2) * 6MWT \<50m OR \>400m * Active endocarditis or infection \< 3 months * Mean Right Atrial Pressure (mRAP) \> 15 mmHg as determined by site cardiologist * Body Mass Index (BMI) ≥ 45 kg/m2

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Conditions

The condition(s) this trial relates to.

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

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • University of Ottawa Heart Institute

    Ottawa, Ontario, Canada

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