ELEVATE-HFpEF Clinical Study
Condition(s) studied
Investigational drug(s) / intervention(s)
Personalized cardiac pacing: Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Study 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
Primary outcome measure(s)
- Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP. — Follow-up duration for endpoint analysis is 12-months.
Cardiovascular mortality, urgent heart failure events, and ODI heart failure events will be collected as they occur. The Kansas City Cardiomyopathy Questionnaire (KCCQ); (range of score is 0 to 100), 6-minute walk test (distance in meters), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (picograms per milliliter, pg/mL) will be collected at Baseline and the 12-months visit. Treatment and control groups will be compared using a win ratio. - Primary Safety Objective: Percentage of patients with major complications related to the system or procedure. — 12-months post pacemaker implant attempt.
Adverse events will be collected as they occur. Adverse events will be adjudicated for their relationship to the implant procedure and system. Severity of adverse events related to the procedure or system will be reviewed to determine if they are major complications. Major complications are defined as complications related to the system or procedure that result in one or more of the following: death, hospitalization, prolonged hospitalization by at least 48 hours, additional surgical intervention, system modification (e.g., reposition, replacement, or explant), and/or permanent loss of device function due to mechanical or electrical dysfunction of the device. The percentage of patients undergoing a pacemaker implant attempt who experience a major complication related to the system or procedure at 12 months.
Trial sites (51)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner - University Medical Center Phoenix | Phoenix | Arizona | Recruiting |
| Stanford University | Palo Alto | California | Recruiting |
| Sutter Health Hospital | San Francisco | California | Recruiting |
| Hartford Hospital | Hartford | Connecticut | Recruiting |
| Cardiovascular Institute of Northwest Florida | Panama City | Florida | Recruiting |
| Emory University | Atlanta | Georgia | Recruiting |
| The University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| Norton Healthcare | Louisville | Kentucky | Recruiting |
| Tufts Medical Center | Boston | Massachusetts | Recruiting |
| M Health Fairview University of Minnesota Medical Center - East Bank | Minneapolis | Minnesota | Recruiting |
| Saint Lukes Mid America Heart Institute | Kansas City | Missouri | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | Recruiting |
| Mount Carmel East | Columbus | Ohio | Recruiting |
| Lancaster General Hospital | Lancaster | Pennsylvania | Recruiting |
| Lankenau Institute for Medical Research | Wynnewood | Pennsylvania | Recruiting |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | Recruiting |
| Saint Thomas Research Institute | Nashville | Tennessee | Recruiting |
| Dallas VA Medical Center | Dallas | Texas | Recruiting |
| Texas Health Research & Education Institute | Fort Worth | Texas | Recruiting |
| The University of Vermont Medical Center | Burlington | Vermont | Recruiting |
| Inova Fairfax Hospital | Falls Church | Virginia | Recruiting |
| Saint Joseph Medical Center (Tacoma WA) | Tacoma | Washington | Recruiting |
| Charleston Area Medical Center (CAMC) Memorial Hospital | Charleston | West Virginia | Recruiting |
| Froedtert Hospital | Milwaukee | Wisconsin | Recruiting |
| The Prince Charles Hospital | Chermside | Queensland | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Ordensklinikum Linz GmbH / Elisabethinen | Linz | Austria | Recruiting |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium | Recruiting |
| University of Calgary | Calgary | Canada | Recruiting |
| Saint Pauls Hospital | Vancouver | Canada | Recruiting |
| Fakultni nemocnice Královské Vinohrady | Prague | Czechia | Recruiting |
| Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz | Besançon | France | Recruiting |
| Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied | Clermont-Ferrand | France | Recruiting |
| Hôpital Guillaume et René Laënnec - CHU de Nantes | Nantes | France | Recruiting |
| CHU Toulouse - Hôpital Rangueil | Toulouse | France | Recruiting |
| Universitätsklinikum Schleswig-Holstein - Campus Lübeck | Lübeck | Germany | Recruiting |
| Prince of Wales Hospital | Hong Kong | Hong Kong | Recruiting |
| Queen Elizabeth Hospital (Hong Kong) | Hong Kong | Hong Kong | Recruiting |
+ 11 more sites — see the full list on the official registry below.
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06678841 on ClinicalTrials.gov ↗ ← All trials in Australia