ELEVATE-HFpEF Clinical Study

NCT06678841 | Recruiting DMC FDA Device

• 1 other identifier: MDT23039
• Study Type: interventional
• Target: 700
• Locations: 13 countries
• Sites: 41

Brief 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).

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Keywords

Heart Failure; Heart Disease; Cardiovascular Disease; Concentric Hypertrophy; Concentric Remodeling

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Follow-up duration for endpoint analysis is 12-months.

• Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.

  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.

  12-months post pacemaker implant attempt.

Secondary Outcomes (5)

• Secondary Objective #1: Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups.

  Follow-up duration for endpoint analysis is 12-months.

• Secondary Objective #2: Compare the change in NT-proBNP from baseline to 12-months between randomized groups by comparing NT-proBNP measured at baseline and 12-months.

  Follow-up duration for endpoint analysis is 12-months.

• Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.

  Follow-up duration for endpoint analysis is 12-months.

• Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.

  Follow-up duration for endpoint analysis is 12-months.

• Secondary Objective #5: Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period.

  Follow-up duration for endpoint analysis is 12-months.

Study Arms (2)

Personalized Pacing Therapy (Treatment Group)

EXPERIMENTAL

The treatment group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide dual chamber pacing at a personalized cardiac pacing rate determined by patient height and baseline LVEF percentage.

Device: Personalized cardiac pacing

Control Group

NO INTERVENTION

The control group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide ventricular pacing at a non-personalized rate. This is considered limited or backup pacing.

Interventions

Personalized cardiac pacing DEVICE

Personalized cardiac pacing treatment based each patient's height and baseline LVEF.

Personalized Pacing Therapy (Treatment Group)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 40 years
• Documented EF ≥50% within the preceding 12 months
• HFpEF defined as:
• 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
• 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

You may not qualify if:

• Improved or recovered EF (i.e., prior LVEF\<50%)
• 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))
• Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
• Average heart rate \<50 bpm or symptomatic bradycardia
• 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.
• Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
• Severe obesity defined as BMI \>45.
• Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \<50 bpm or evidence of ventricular pauses exceeding 6 seconds
• Planned AF ablation
• Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
• Hypertrophic cardiomyopathies
• Uncontrolled hypertension as defined by BP \>160/100 mmHg on two measurements ≥15 minutes apart
• End Stage Renal Disease (CKD 4 or greater)
• More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
• Significant primary pulmonary disease on home oxygen

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (42)

Banner - University Medical Center Phoenix

Phoenix, Arizona, 85006, United States

RECRUITING

Sutter Health Hospital

San Francisco, California, 94107, United States

RECRUITING

Hartford Hospital

Hartford, Connecticut, 06106, United States

RECRUITING

Cardiovascular Institute of Northwest Florida

Panama City, Florida, 32405, United States

RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Norton Healthcare

Louisville, Kentucky, 40295, United States

RECRUITING

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

M Health Fairview University of Minnesota Medical Center - East Bank

Minneapolis, Minnesota, 55455, United States

RECRUITING

Saint Lukes Mid America Heart Institute

Kansas City, Missouri, 64111, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Mount Carmel East

Columbus, Ohio, 43219, United States

RECRUITING

Lancaster General Hospital

Lancaster, Pennsylvania, 17602, United States

RECRUITING

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

RECRUITING

Saint Thomas Research Institute

Nashville, Tennessee, 37203, United States

RECRUITING

Dallas VA Medical Center

Dallas, Texas, 75216, United States

RECRUITING

Texas Health Research & Education Institute

Fort Worth, Texas, 76104, United States

RECRUITING

The University of Vermont Medical Center

Burlington, Vermont, 05401, United States

RECRUITING

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

RECRUITING

Charleston Area Medical Center (CAMC) Memorial Hospital

Charleston, West Virginia, 25304, United States

RECRUITING

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

RECRUITING

The Prince Charles Hospital

Chermside, Queensland, 4032, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Ordensklinikum Linz GmbH / Elisabethinen

Linz, 4010, Austria

RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, 2650, Belgium

RECRUITING

Saint Pauls Hospital

Vancouver, V6Z 1Y6, Canada

RECRUITING

Fakultni nemocnice Královské Vinohrady

Prague, 100 34, Czechia

RECRUITING

Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

Besançon, 25030, France

RECRUITING

Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

Clermont-Ferrand, 63003, France

RECRUITING

CHU Toulouse - Hôpital Rangueil

Toulouse, 50032, France

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Queen Elizabeth Hospital (Hong Kong)

Hong Kong, Hong Kong

RECRUITING

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

RECRUITING

Sarawak Heart Centre

Kota Samarahan, 94300, Malaysia

RECRUITING

Oslo Universitetssykehus-Rikshospitalet

Oslo, 0372, Norway

RECRUITING

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Hôpitaux Universitaires de Genève

Geneva, 1205, Switzerland

RECRUITING

The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

Leeds, LS1 3EX, United Kingdom

RECRUITING

Manchester University NHS Foundation Trust - Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Dawn Dyer

CONTACT

954-682-8334; dawn.dyer@medtronic.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Primary and secondary endpoints are measured until 12 months post implant. At the 12-month visit, the second group (control group) will be crossed over and programmed to their personalized cardiac pacing rate receiving treatment group therapy for the remainder of follow-up until the subject is exited.

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 7, 2024
• Study Start: July 9, 2025
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); FR (3); MY (1); JP (1); CA (1); AU (2); NO (1); HK (2); SL (1); CZ (1); GB (2); CH (1); BE (1)