RecruitingNot ApplicableNCT06678841

ELEVATE-HFpEF Clinical Study

Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Enrollment

700 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

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).

Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tests a device-based therapy (ELEVATE) designed to improve exercise capacity in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but becomes too stiff to fill properly, causing breathlessness and fatigue. **You may be eligible if...** - You are 40 or older - You have been diagnosed with HFpEF (heart failure with preserved pumping function, EF ≥50%) - You had a recent hospitalization or urgent clinic visit for worsening heart failure in the past year - You experience shortness of breath or fatigue that limits your activity **You may NOT be eligible if...** - Your heart failure is due to reduced ejection fraction (systolic heart failure) - You have severe valve disease, recent heart attack, or major cardiac procedure recently - You have significant kidney disease or other conditions limiting participation - You are pregnant - You have had a prior procedure with the study device Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEPersonalized cardiac pacing

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

Locations(34)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 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

Norton Healthcare

Louisville, Kentucky, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Saint Lukes Mid America Heart Institute

Kansas City, Missouri, 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

The University of Vermont Medical Center

Burlington, Vermont, United States

Inova Fairfax Hospital

Falls Church, Virginia, United States

Charleston Area Medical Center (CAMC) Memorial Hospital

Charleston, West Virginia, 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

Saint Pauls Hospital

Vancouver, Canada

Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

Besançon, France

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, France

CHU Toulouse - Hôpital Rangueil

Toulouse, France

Prince of Wales Hospital

Hong Kong, Hong Kong

Queen Elizabeth Hospital (Hong Kong)

Hong Kong, Hong Kong

Sarawak Heart Centre

Kota Samarahan, 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

Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06678841

Related Trials

Characteristics, Phenotypes, and TRAITS of Heart Failure With Preserved Ejection Fraction (TRAITS-HFpEF)

NCT053832871 location

Exercise Capacity According to Coronary Microvascular Dysfunction and Body Composition

NCT048226491 location