ELEVATE-HFpEF Clinical Study
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
Interventions
Personalized cardiac pacing
Conditions
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