AzTrials
AzTrials

Heart Failure With Preserved Ejection Fraction (HFpEF)ELEVATE-HFpEFNCT06678841

ELEVATE-HFpEF Clinical Study

A study testing Personalized cardiac pacing in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in 15 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Personalized cardiac pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
51 sitesin 15 countries
Study dates
9 Jul 2025to Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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
  • Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
  • 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)
  • Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).

Who cannot join

  • 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.
Show all 19Show fewer
  • 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
  • Known contraindication for a pacemaker implant
  • Advanced co-morbidity with life expectancy < 1 year
  • 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.
  • Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).

Trial locations and contacts

51 sites in 15 countries. Contact the study team or a site near you to ask about taking part.

Dawn Dyer contact

954-682-8334

dawn.dyer@medtronic.com

51 sites in 15 countries

United States26 sites, 26 recruiting

  • Emory University

    Atlanta, Georgia, 30308

    Recruiting

  • Tufts Medical Center

    Boston, Massachusetts, 02111

    Recruiting

  • The University of Vermont Medical Center

    Burlington, Vermont, 05401

    Recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Recruiting

  • Charleston Area Medical Center (CAMC) Memorial Hospital

    Charleston, West Virginia, 25304

    Recruiting

  • The University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

    Recruiting

  • Mount Carmel East

    Columbus, Ohio, 43219

    Recruiting

  • Dallas VA Medical Center

    Dallas, Texas, 75216

    Recruiting

  • Duke University Medical Center

    Durham, North Carolina, 27710

    Recruiting

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

    Recruiting

  • Texas Health Research & Education Institute

    Fort Worth, Texas, 76104

    Recruiting

  • Hartford Hospital

    Hartford, Connecticut, 06106

    Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

    Recruiting

  • Saint Lukes Mid America Heart Institute

    Kansas City, Missouri, 64111

    Recruiting

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

    Recruiting

  • Norton Healthcare

    Louisville, Kentucky, 40295

    Recruiting

  • Froedtert Hospital

    Milwaukee, Wisconsin, 53226

    Recruiting

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455

    Recruiting

  • Saint Thomas Research Institute

    Nashville, Tennessee, 37203

    Recruiting

  • Stanford University

    Palo Alto, California, 94304

    Recruiting

  • Cardiovascular Institute of Northwest Florida

    Panama City, Florida, 32405

    Recruiting

  • Banner - University Medical Center Phoenix

    Phoenix, Arizona, 85006

    Recruiting

  • Sutter Health Hospital

    San Francisco, California, 94107

    Recruiting

  • Saint Joseph Medical Center (Tacoma WA)

    Tacoma, Washington, 98405

    Recruiting

  • Lankenau Institute for Medical Research

    Wynnewood, Pennsylvania, 19096

    Recruiting

Other trials in United States

France4 sites, 4 recruiting

  • Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz

    Besançon, 25030

    Recruiting

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, 63003

    Recruiting

  • Hôpital Guillaume et René Laënnec - CHU de Nantes

    Nantes, 44093

    Recruiting

  • CHU Toulouse - Hôpital Rangueil

    Toulouse, 50032

    Recruiting

Other trials in France

Japan3 sites, 3 recruiting

  • Chiba University Hospital

    Chiba, Chiba, 260-8677

    Recruiting

  • Kokura Memorial Hospital

    Kitakyushu, Fukuoka, 802-8555

    Recruiting

  • National Cerebral and Cardiovascular Center

    Suita, Osaka, 564-8565

    Recruiting

Other trials in Japan

United Kingdom3 sites, 3 recruiting

  • The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary

    Leeds, LS1 3EX

    Recruiting

  • Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital

    London, SE1 7EH

    Recruiting

  • Manchester University NHS Foundation Trust - Manchester Royal Infirmary

    Manchester, M13 9WL

    Recruiting

Other trials in United Kingdom

Australia2 sites, 2 recruiting

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

Other trials in Australia

Canada2 sites, 2 recruiting

  • University of Calgary

    Calgary, T2N 2T9

    Recruiting

  • Saint Pauls Hospital

    Vancouver, V6Z 1Y6

    Recruiting

Other trials in Canada

Hong Kong2 sites, 2 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Recruiting

  • Queen Elizabeth Hospital (Hong Kong)

    Hong Kong

    Recruiting

Other trials in Hong Kong

Malaysia2 sites, 2 recruiting

  • Sarawak Heart Centre

    Kota Samarahan, 94300

    Recruiting

  • Institut Jantung Negara - National Heart Institute

    Kuala Lumpur, 50400

    Recruiting

Other trials in Malaysia

Austria1 site, 1 recruiting

  • Ordensklinikum Linz GmbH / Elisabethinen

    Linz, 4010

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

    Recruiting

Other trials in Belgium

Czechia1 site, 1 recruiting

  • Fakultni nemocnice Královské Vinohrady

    Prague, 100 34

    Recruiting

Other trials in Czechia

Germany1 site, 1 recruiting

  • Universitätsklinikum Schleswig-Holstein - Campus Lübeck

    Lübeck, 23538

    Recruiting

Other trials in Germany

Norway1 site, 1 recruiting

  • Oslo Universitetssykehus-Rikshospitalet

    Oslo, 0372

    Recruiting

Other trials in Norway

Slovenia1 site, 1 recruiting

  • University Medical Centre Ljubljana

    Ljubljana, 1000

    Recruiting

Other trials in Slovenia

Switzerland1 site, 1 recruiting

  • Hôpitaux Universitaires de Genève

    Geneva, 1205

    Recruiting

Other trials in Switzerland

About this study

Official title: Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)

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).

Read the 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.

Being tested
Personalized cardiac pacing
Keywords
Heart Failure, Heart Disease, Cardiovascular Disease, Concentric Hypertrophy, Concentric Remodeling
Medical subject headings
Heart Failure, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Personalized cardiac pacingDevice

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

Study groups in NCT06678841
Study groupRoleWhat they receive
Personalized Pacing Therapy (Treatment Group)ExperimentalThe 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.
Receives: Device: Personalized cardiac pacing
Control GroupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 12-months post pacemaker implant attempt.

Secondary outcomes (5)

  1. 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.

    KCCQ will be collected at baseline and 12-months and the clinical summary score (CSS) will be computed with a range of 0 to 100, 100 being the best score. The change in KCCQ-CCS will be compared between the treatment and control groups.

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

  2. 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.

    NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups.

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

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

    AF burden (percentage of time in atrial fibrillation) is collected by the pacemaker system. AF burden will be compared between treatment and control groups.

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

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

    The 6-minute walk test will be performed at baseline and 12-months. The change in walk test distance (in meters) from baseline to 12-months will be compared between the treatment and control groups.

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

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

    Physical activity (hours per day) is collected by the pacemaker system. The average physical activity during the 12-month follow-up period will be compared between the treatment and control group.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2024
  2. Study start9 Jul 2025
  3. Primary completionAug 2028 (estimated)
  4. Study completionFeb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06678841
Sponsor's protocol ID
MDT23039
Acronym
ELEVATE-HFpEF
Status last verified
Jun 2026
First submitted
14 Oct 2024
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Personalized cardiac pacing in people with Heart Failure With Preserved Ejection Fraction (HFpEF), run by Medtronic Cardiac Rhythm and Heart Failure at 51 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in United States, France, Japan, United Kingdom, Australia and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dawn Dyer (954-682-8334, dawn.dyer@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Follow-up duration for endpoint analysis is 12-months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06678841.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in