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RECRUITING
NCT06678841
NA

ELEVATE-HFpEF Clinical Study

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

700

Start Date

2025-07-09

Completion Date

2029-02

Last Updated

2026-03-30

Healthy Volunteers

No

Interventions

DEVICE

Personalized 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