Back to Trials
NCT06678841NARecruiting

ELEVATE-HFpEF Clinical Study

Medtronic Cardiac Rhythm and Heart Failure

Start Date

7/9/2025

Completion Date

2/1/2029

Summary

ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

Detailed Description

This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group). Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.

Eligibility Criteria

Age Range: 40 years to No maximum

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).

Interventions

DEVICE

Personalized cardiac pacing

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Locations

Banner - University Medical Center Phoenix

Phoenix, Arizona 85006

United States

Sutter Health Hospital

San Francisco, California 94107

United States

Hartford Hospital

Hartford, Connecticut 06106

United States

Cardiovascular Institute of Northwest Florida

Panama City, Florida 32405

United States

Emory University

Atlanta, Georgia 30308

United States

The University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Norton Healthcare

Louisville, Kentucky 40295

United States

Cardiovascular Institute of the South

Houma, Louisiana 70360

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota 55455

United States

Saint Lukes Mid America Heart Institute

Kansas City, Missouri 64111

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States

Mount Carmel East

Columbus, Ohio 43219

United States

Lancaster General Hospital

Lancaster, Pennsylvania 17602

United States

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania 19096

United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina 29425

United States

Saint Thomas Research Institute

Nashville, Tennessee 37203

United States

Dallas VA Medical Center

Dallas, Texas 75216

United States

Texas Health Research & Education Institute

Fort Worth, Texas 76104

United States

The University of Vermont Medical Center

Burlington, Vermont 05401

United States

Inova Fairfax Hospital

Falls Church, Virginia 22042

United States

Saint Joseph Medical Center (Tacoma WA)

Tacoma, Washington 98405

United States

Charleston Area Medical Center (CAMC) Memorial Hospital

Charleston, West Virginia 25304

United States

Froedtert Hospital

Milwaukee, Wisconsin 53226

United States

The Prince Charles Hospital

Chermside, Queensland 4032

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Ordensklinikum Linz GmbH / Elisabethinen

Linz, 4010

Austria

Universitair Ziekenhuis Antwerpen

Edegem, 2650

Belgium

University of Calgary

Calgary, T2N 2T9

Canada

Saint Pauls Hospital

Vancouver, V6Z 1Y6

Canada

Fakultni nemocnice Královské Vinohrady

Prague, 100 34

Czechia

Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

Besançon, 25030

France

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, 63003

France

CHU Toulouse - Hôpital Rangueil

Toulouse, 50032

France

Prince of Wales Hospital

Hong Kong,

Hong Kong

Queen Elizabeth Hospital (Hong Kong)

Hong Kong,

Hong Kong

Kokura Memorial Hospital

Kitakyushu, Fukuoka 802-8555

Japan

Sarawak Heart Centre

Kota Samarahan, 94300

Malaysia

Institut Jantung Negara - National Heart Institute

Kuala Lumpur, 50400

Malaysia

Oslo Universitetssykehus-Rikshospitalet

Oslo, 0372

Norway

University Medical Centre Ljubljana

Ljubljana, 1000

Slovenia

Hôpitaux Universitaires de Genève

Geneva, 1205

Switzerland

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds, LS1 3EX

United Kingdom

Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Manchester, M13 9WL

United Kingdom