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Tiny heart device tested in MRI study for common type of heart failure

NCT ID NCT07093528

Knowledge-focused Sponsor: Mayo Clinic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 uses a special heart MRI to see if a device called a coronary sinus reducer can improve blood flow in patients with heart failure with preserved ejection fraction (HFpEF) and coronary microvascular dysfunction (small vessel disease). The device is implanted to reroute blood flow in the heart. Researchers will measure changes in blood flow to the inner layer of the heart muscle. The study enrolls 25 adults who are already in a larger trial of the device.

What this could mean

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

Active substance
Coronary sinus reducer (a device implanted to improve blood flow in the heart)
What this could lead to
If successful, this could show that the coronary sinus reducer improves blood flow to the heart muscle in patients with heart failure and small vessel disease.
What could go wrong
This is a very small, early substudy (25 people) that only measures changes on MRI. It may not prove any real-world benefit or safety.

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.

Participants

About 25 people

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

Started

Oct 2025

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Who is studied

Subjects included in the main CS-reducer HFPEF study (IRB# 25-002292)

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: * Age ≥18 * Enrollment in main CS-reducer HFPEF study IRB# 25-002292 Exclusion Criteria: * Metal implants that are not suitable for MRI * Inability or unwillingness of individual to give written informed consent.

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Conditions

The condition(s) this trial relates to.

coronary microvascular disorder diastolic heart failure

As listed by the trial registrant

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

Coronary microvascular dysfunction Heart failure with preserved ejection fraction

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

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