Actively Recruiting
ELEVATE-HFpEF Clinical Study
Led by Medtronic Cardiac Rhythm and Heart Failure · Updated on 2026-05-04
700
Participants Needed
42
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
ELEVATE-HFpEF Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Documented left ventricular ejection fraction (LVEF) of 50% or higher within the past 12 months
- Heart failure with preserved ejection fraction (HFpEF) defined by either a recent worsening heart failure episode or symptoms of breathlessness with NYHA class II or higher plus at least one specific clinical or imaging criterion
- Stable heart failure medical treatment for at least 30 days
- Average heart rate on baseline monitoring at least 5 bpm lower than personalized cardiac pacing rate
- Ability and willingness to follow study procedures and ambulate independently at baseline
You will not qualify if you...
- Improved or recovered ejection fraction below 50%
- Having or planned implantation of a cardiac device capable of pacing (pacemaker, ICD, CRT)
- Current pregnancy
- Average heart rate below 50 bpm or symptomatic slow heart rate
- Recent acute coronary syndrome, heart surgery, or urgent cardiac procedures within specified time frames
- Current acute decompensated heart failure requiring intravenous treatments
- Severe obesity with BMI over 45
- Persistent or permanent atrial fibrillation with low heart rate or long pauses
- Planned atrial fibrillation ablation procedure
- Certain heart muscle diseases like amyloidosis or hypertrophic cardiomyopathy
- Uncontrolled high blood pressure
- End stage kidney disease (chronic kidney disease stage 4 or higher)
- More than moderate heart valve disease
- Significant lung disease requiring oxygen at home
- Known contraindications for pacemaker implantation
- Advanced illness with life expectancy less than one year
- Participation in other conflicting clinical trials without approval
- Vulnerable adults unable to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States, 85006
Actively Recruiting
2
Sutter Health Hospital
San Francisco, California, United States, 94107
Actively Recruiting
3
Hartford Hospital
Hartford, Connecticut, United States, 06106
Actively Recruiting
4
Cardiovascular Institute of Northwest Florida
Panama City, Florida, United States, 32405
Actively Recruiting
5
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
6
The University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
7
Norton Healthcare
Louisville, Kentucky, United States, 40295
Actively Recruiting
8
Cardiovascular Institute of the South
Houma, Louisiana, United States, 70360
Actively Recruiting
9
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
10
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
11
Saint Lukes Mid America Heart Institute
Kansas City, Missouri, United States, 64111
Actively Recruiting
12
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
13
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Mount Carmel East
Columbus, Ohio, United States, 43219
Actively Recruiting
15
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17602
Actively Recruiting
16
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Actively Recruiting
17
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425
Actively Recruiting
18
Saint Thomas Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
19
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Actively Recruiting
20
Texas Health Research & Education Institute
Fort Worth, Texas, United States, 76104
Actively Recruiting
21
The University of Vermont Medical Center
Burlington, Vermont, United States, 05401
Actively Recruiting
22
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Actively Recruiting
23
Charleston Area Medical Center (CAMC) Memorial Hospital
Charleston, West Virginia, United States, 25304
Actively Recruiting
24
Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
25
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Actively Recruiting
26
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
27
Ordensklinikum Linz GmbH / Elisabethinen
Linz, Austria, 4010
Actively Recruiting
28
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Actively Recruiting
29
Saint Pauls Hospital
Vancouver, Canada, V6Z 1Y6
Actively Recruiting
30
Fakultni nemocnice Královské Vinohrady
Prague, Czechia, 100 34
Actively Recruiting
31
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
Besançon, France, 25030
Actively Recruiting
32
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, France, 63003
Actively Recruiting
33
CHU Toulouse - Hôpital Rangueil
Toulouse, France, 50032
Actively Recruiting
34
Prince of Wales Hospital
Hong Kong, Hong Kong
Actively Recruiting
35
Queen Elizabeth Hospital (Hong Kong)
Hong Kong, Hong Kong
Actively Recruiting
36
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan, 802-8555
Actively Recruiting
37
Sarawak Heart Centre
Kota Samarahan, Malaysia, 94300
Actively Recruiting
38
Oslo Universitetssykehus-Rikshospitalet
Oslo, Norway, 0372
Actively Recruiting
39
University Medical Centre Ljubljana
Ljubljana, Slovenia, 1000
Actively Recruiting
40
Hôpitaux Universitaires de Genève
Geneva, Switzerland, 1205
Actively Recruiting
41
The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
Leeds, United Kingdom, LS1 3EX
Actively Recruiting
42
Manchester University NHS Foundation Trust - Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Actively Recruiting
Research Team
D
Dawn Dyer
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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