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No-implant heart procedure aims to help failing hearts

NCT ID NCT06859970

Symptom relief Sponsor: InterShunt Technologies, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early study tests a device that creates a small, temporary opening in the wall of the heart to relieve pressure and improve symptoms in people with advanced heart failure. The main goal is to see if the procedure is safe. About 20 participants who have not responded well to standard treatments will be enrolled.

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 20 people

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

Started

May 2025

Expected to finish

Sep 2031

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

40 to 85 years

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: * NYHA Class II at screening with a prior history of greater than NYHA Class II, OR NYHA Class III at screening, OR ambulatory Class IV at screening: with documented medical history of heart failure for at least 6 months prior to the screening visit. * At least one hospitalization for heart failure OR treatment with IV diuretics for heart failure OR elevated BNP in the prior 12 months. * Receiving maximally tolerated guideline directed medical therapy for Heart Failure management. * LVEF ≥ 20% and ≤ 40% according to baseline echocardiography. * Resting right heart catheterization demonstrates elevated PCWP compared to right atrial pressure. Exclusion Criteria: * Any of the following within the prior 6 months: Stroke, thromboembolism, severe or advanced heart failure such as Stage D heart failure, non-ambulatory NYHA Class IV, cardiac index less than 1.8 L/min/m2, LVEDD \> 8 cm, or received inotropic therapy for LVEF less than 20%. * Any of the following within the prior 3 months: Myocardial infarction percutaneous cardiac intervention, CABG, on cardiac transplant list, cardiac resynchronization therapy implant, AICD implant, or indicated for coronary revascularization at the time of enrollment. * Transseptal procedure or percutaneous cardiac intervention planned within the next 6 months. * Chronic pulmonary disease requiring continuous home oxygen or hospitalization within the prior 12 months for pulmonary disease. * Patent foramen ovale (PFO) device or atrial septal defect (ASD) device. * BMI \> 40. * Anatomic anomaly that precludes creation of interatrial shunt.

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Conditions

The condition(s) this trial relates to.

heart failure moderate heart failure systolic heart failure

As listed by the trial registrant

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

Ambulatory heart failure, nyha class IV Heart failure Heart failure nyha class III Heart failure with reduced ejection fraction

Contacts and locations

Locations

  • Ascension St. Vincent Hospital

    Indianapolis, Indiana, 46260, United States

  • Christ Hospital

    Cincinnati, Ohio, 45219, United States

  • Los Robles Health System

    Thousand Oaks, California, 91360, United States

  • Methodist Healthcare

    San Antonio, Texas, 78229, United States

  • St. Bernard's Healthcare

    Jonesboro, Arkansas, 72401, United States

  • The Ohio State University

    Columbus, Ohio, 43210, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.