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Pacemaker upgrade could ease stiff heart failure

NCT ID NCT07598760

Disease control Sponsor: BackBeat Medical 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests a special pacemaker-like device called Moderato Plus in 20 people with high blood pressure and a type of heart failure where the heart pumps normally but is too stiff (HFpEF). The device delivers Cardiac Neuromodulation Therapy to help control blood pressure and improve heart function during rest and exercise. Participants will be followed for up to 12 months to see if the therapy is feasible and safe.

What this could mean

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

Active substance
Moderato Plus device with Cardiac Neuromodulation Therapy (CNT)
What this could lead to
If successful, this could point toward a new device-based treatment to improve heart function and blood pressure control in people with HFpEF.
What could go wrong
This is a very small pilot study with only 20 participants, so results may not apply to everyone. The device is still experimental, and long-term benefits or risks are unknown.

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.

Expected to start

May 2026

An estimate. Start dates often move.

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: * Adults aged 18 years or older * Clinical indication for dual-chamber pacemaker implantation or replacement * Diagnosis of heart failure with preserved ejection fraction (HFpEF), defined as left ventricular ejection fraction ≥50% * History of hypertension * NYHA functional class II or III * On stable guideline-directed medical therapy * Able and willing to provide written informed consent Exclusion Criteria: * NYHA class IV heart failure * Permanent or persistent atrial fibrillation * Recent acute decompensated heart failure * Significant valvular heart disease requiring intervention * Severe comorbid conditions that, in the investigator's judgment, would make study participation unsafe * Pregnant or breastfeeding individuals

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Conditions

The condition(s) this trial relates to.

diastolic heart failure hypertensive disorder Isolated Systolic Hypertension

As listed by the trial registrant

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

Heart failure with preserved ejection fraction (hfpef Hypertension (HTN) Hypertension, systolic

How to take part

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

  1. The places running it

    2 sites. 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

  • Georgian Medical Research Clinic Healthycore

    Tbilisi, Georgia

  • Tbilisi Heart and Vascular Clinic

    Tbilisi, Georgia

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