Heart Failure With Preserved Ejection Fraction (HFpEF)
Investigational drug(s) / intervention(s)
Personalized cardiac pacing
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
Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 40 years
2. Documented EF ≥50% within the preceding 12 months
3. HFpEF defined as:
1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR
2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
* Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
* Elevated NT-proBNP in the last year defined as \>400 pg/m for patients with no AF or paroxysmal AF, or \>900 pg/ml for patients with ≥persistent AF
* Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)
* Echo criteria defined by ≥2 of:
* LV wall thickness ≥ 12 mm
* LV mass index (BSA indexed LVH): sex at birth male \>115 g/m2, sex at birth female \>95 g/m2
* Relative wall thickness ≥0.42
* E/e' ≥15 in sinus rhythm (or \> 11 in the setting of atrial fibrillation) OR septal \<7 cm/s or lateral e' \<10cm/s
* Tricuspid regurgitation (TR) velocity \>2.8 m/s
* Left atrial (LA) enlargement, defined by LA volume index \>34 ml/m2
4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)
6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion Criteria:
1. Improved or recovered EF (i.e., prior LVEF\<50%)
2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
4. Average heart rate \<50 bpm or symptomatic bradycardia
5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
7. Severe obesity defined as BMI \>45.
8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
9. Planned AF ablation
10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
11. Hypertrophic cardiomyopathies
12. Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
13. End Stage Renal Disease (CKD 4 or greater)
14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
15. Significant primary pulmonary disease on home oxygen
16. Known contraindication for a pacemaker implant
17. Advanced co-morbidity with life expectancy \< 1 year
18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.
19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
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 (50)
Facility
City
Region
Status
Banner - University Medical Center Phoenix
Phoenix
Arizona
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
Cardiovascular Institute of the South
Houma
Louisiana
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
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
Chiba University Hospital
Chiba
Chiba
Recruiting
+ 10 more sites — see the full list on the official registry below.
More Medtronic Cardiac Rhythm and Heart Failure trials in the USA
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.