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Could a smarter pacemaker ease a common type of heart failure?

NCT ID NCT06678841

Disease control Sponsor: Medtronic Cardiac Rhythm and Heart Failure 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Updated 4 times

Summary

This study tests whether a pacemaker programmed to each person's needs can improve symptoms and outcomes for people with a common type of heart failure (HFpEF). About 700 adults with heart failure but normal pumping strength will receive either personalized pacing or minimal/no pacing. The goal is to see if this approach reduces heart-related deaths, hospitalizations, and improves quality of life.

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 700 people

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

Started

Jul 2025

Expected to finish

Feb 2029

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 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: 1. Age ≥ 40 years 2. Documented EF ≥50% within the preceding 12 months 3. HFpEF defined as: 1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR 2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA: * Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure * Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs) * Echo criteria defined by ≥2 of: * LV wall thickness ≥ 12 mm * LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2 * Relative wall thickness ≥0.42 * E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \<7 cm/s or lateral e' \<10cm/s * Tricuspid regurgitation (TR) velocity \>2.8 m/s * Left atrial (LA) enlargement, defined by LA volume index \>34 ml/m2 4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days 5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible) 6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline). Exclusion Criteria: 1. Improved or recovered EF (i.e., prior LVEF\<50%) 2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT)) 3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction) 4. Average heart rate \<50 bpm or symptomatic bradycardia 5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit. 6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs. 7. Severe obesity defined as BMI \>45. 8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds 9. Planned AF ablation 10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis) 11. Hypertrophic cardiomyopathies 12. Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart 13. End Stage Renal Disease (CKD 4 or greater) 14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease) 15. Significant primary pulmonary disease on home oxygen 16. Known contraindication for a pacemaker implant 17. Advanced co-morbidity with life expectancy \< 1 year 18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager. 19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diastolic heart failure heart disorder heart failure

As listed by the trial registrant

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

Heart failure with preserved ejection fraction (hfpef

How to take part

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

  1. The places running it

    50 sites in 15 countries. 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

  • Banner - University Medical Center Phoenix

    RECRUITING

    Phoenix, Arizona, 85006, United States

  • CHU Toulouse - Hôpital Rangueil

    RECRUITING

    Toulouse, 50032, France

  • Cardiovascular Institute of Northwest Florida

    RECRUITING

    Panama City, Florida, 32405, United States

  • Cardiovascular Institute of the South

    RECRUITING

    Houma, Louisiana, 70360, United States

  • Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

    RECRUITING

    Besançon, 25030, France

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    RECRUITING

    Clermont-Ferrand, 63003, France

  • Charleston Area Medical Center (CAMC) Memorial Hospital

    RECRUITING

    Charleston, West Virginia, 25304, United States

  • Chiba University Hospital

    RECRUITING

    Chiba, Chiba, 260-8677, Japan

  • Dallas VA Medical Center

    RECRUITING

    Dallas, Texas, 75216, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Fakultni nemocnice Královské Vinohrady

    RECRUITING

    Prague, 100 34, Czechia

  • Froedtert Hospital

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital

    RECRUITING

    London, SE1 7EH, United Kingdom

  • Hartford Hospital

    RECRUITING

    Hartford, Connecticut, 06106, United States

  • Hôpitaux Universitaires de Genève

    RECRUITING

    Geneva, 1205, Switzerland

  • Inova Fairfax Hospital

    RECRUITING

    Falls Church, Virginia, 22042, United States

  • Institut Jantung Negara - National Heart Institute

    RECRUITING

    Kuala Lumpur, 50400, Malaysia

  • Kokura Memorial Hospital

    RECRUITING

    Kitakyushu, Fukuoka, 802-8555, Japan

  • Lancaster General Hospital

    RECRUITING

    Lancaster, Pennsylvania, 17602, United States

  • Lankenau Institute for Medical Research

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • M Health Fairview University of Minnesota Medical Center - East Bank

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • Manchester University NHS Foundation Trust - Manchester Royal Infirmary

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Medical University of South Carolina (MUSC)

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mount Carmel East

    RECRUITING

    Columbus, Ohio, 43219, United States

  • National Cerebral and Cardiovascular Center

    RECRUITING

    Suita, Osaka, 564-8565, Japan

  • Norton Healthcare

    RECRUITING

    Louisville, Kentucky, 40295, United States

  • Ordensklinikum Linz GmbH / Elisabethinen

    RECRUITING

    Linz, 4010, Austria

  • Oslo Universitetssykehus-Rikshospitalet

    RECRUITING

    Oslo, 0372, Norway

  • Prince of Wales Hospital

    RECRUITING

    Hong Kong, Hong Kong

  • Queen Elizabeth Hospital (Hong Kong)

    RECRUITING

    Hong Kong, Hong Kong

  • Saint Joseph Medical Center (Tacoma WA)

    RECRUITING

    Tacoma, Washington, 98405, United States

  • Saint Lukes Mid America Heart Institute

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Saint Pauls Hospital

    RECRUITING

    Vancouver, V6Z 1Y6, Canada

  • Saint Thomas Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Sarawak Heart Centre

    RECRUITING

    Kota Samarahan, 94300, Malaysia

  • Sutter Health Hospital

    RECRUITING

    San Francisco, California, 94107, United States

  • Texas Health Research & Education Institute

    RECRUITING

    Fort Worth, Texas, 76104, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

    RECRUITING

    Leeds, LS1 3EX, United Kingdom

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Prince Charles Hospital

    RECRUITING

    Chermside, Queensland, 4032, Australia

  • The University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • The University of Vermont Medical Center

    RECRUITING

    Burlington, Vermont, 05401, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • Universitair Ziekenhuis Antwerpen

    RECRUITING

    Edegem, 2650, Belgium

  • University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

  • University of Calgary

    RECRUITING

    Calgary, T2N 2T9, Canada

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    RECRUITING

    Lübeck, 23538, Germany

More trials for these conditions

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