RECRUITING Not applicable ClinicalTrials.gov

ELEVATE-HFpEF Clinical Study

Sponsor: Medtronic Cardiac Rhythm and Heart Failure • ClinicalTrials.gov ID: NCT06678841

Registry updated: 2026-10-02

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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).

Interventions

Personalized cardiac pacing (Device)
Personalized cardiac pacing treatment based each patient's height and baseline LVEF.

Eligibility criteria

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).

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Locations

Banner - University Medical Center Phoenix — Phoenix, Arizona, United States
Stanford University — Palo Alto, California, United States
Sutter Health Hospital — San Francisco, California, United States
Hartford Hospital — Hartford, Connecticut, United States
Cardiovascular Institute of Northwest Florida — Panama City, Florida, United States
Emory University — Atlanta, Georgia, United States
The University of Chicago Medical Center — Chicago, Illinois, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Norton Healthcare — Louisville, Kentucky, United States
Tufts Medical Center — Boston, Massachusetts, United States
M Health Fairview University of Minnesota Medical Center - East Bank — Minneapolis, Minnesota, United States
Saint Lukes Mid America Heart Institute — Kansas City, Missouri, United States
Duke University Medical Center — Durham, North Carolina, United States
The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
Mount Carmel East — Columbus, Ohio, United States
Lancaster General Hospital — Lancaster, Pennsylvania, United States
Lankenau Institute for Medical Research — Wynnewood, Pennsylvania, United States
Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
Saint Thomas Research Institute — Nashville, Tennessee, United States
Dallas VA Medical Center — Dallas, Texas, United States
Texas Health Research & Education Institute — Fort Worth, Texas, United States
The University of Vermont Medical Center — Burlington, Vermont, United States
Inova Fairfax Hospital — Falls Church, Virginia, United States
Saint Joseph Medical Center (Tacoma WA) — Tacoma, Washington, United States
Charleston Area Medical Center (CAMC) Memorial Hospital — Charleston, West Virginia, United States
Froedtert Hospital — Milwaukee, Wisconsin, United States
The Prince Charles Hospital — Chermside, Queensland, Australia
The Alfred Hospital — Melbourne, Victoria, Australia
Ordensklinikum Linz GmbH / Elisabethinen — Linz, Austria
Universitair Ziekenhuis Antwerpen — Edegem, Belgium
University of Calgary — Calgary, Canada
Saint Pauls Hospital — Vancouver, Canada
Fakultni nemocnice Královské Vinohrady — Prague, Czechia
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz — Besançon, France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied — Clermont-Ferrand, France
Hôpital Guillaume et René Laënnec - CHU de Nantes — Nantes, France
CHU Toulouse - Hôpital Rangueil — Toulouse, France
Universitätsklinikum Schleswig-Holstein - Campus Lübeck — Lübeck, Germany
Prince of Wales Hospital — Hong Kong, Hong Kong
Queen Elizabeth Hospital (Hong Kong) — Hong Kong, Hong Kong
Chiba University Hospital — Chiba, Chiba, Japan
Kokura Memorial Hospital — Kitakyushu, Fukuoka, Japan
National Cerebral and Cardiovascular Center — Suita, Osaka, Japan
Sarawak Heart Centre — Kota Samarahan, Malaysia
Institut Jantung Negara - National Heart Institute — Kuala Lumpur, Malaysia
Oslo Universitetssykehus-Rikshospitalet — Oslo, Norway
University Medical Centre Ljubljana — Ljubljana, Slovenia
Hôpitaux Universitaires de Genève — Geneva, Switzerland
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary — Leeds, United Kingdom
Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital — London, United Kingdom
Manchester University NHS Foundation Trust - Manchester Royal Infirmary — Manchester, United Kingdom

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment