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ELEVATE-HFpEF Study: Personalized Pacing for Heart Failure

The ELEVATE-HFpEF study is testing a personalized cardiac pacing treatment for people with Heart Failure with Preserved Ejection Fraction (HFpEF). This is a type of heart failure where the heart muscle pumps normally, but the heart's main chamber is stiff and doesn't fill properly. You might be able to join if you are at least 40 years old and have documented HFpEF. The study aims to see if this personalized pacing can improve your health, reduce hospital visits for heart failure, and improve your quality of life and exercise ability. The study is currently unclear on its recruitment status and plans to enroll 700 participants.

Study design
This is a randomized, controlled, double-blinded study comparing personalized cardiac pacing to minimal or no pacing. About 700 participants will be enrolled.
What's involved
You would have a pacemaker implanted, followed by visits at 2, 6, 12, 14, 18, and 24 months, and then yearly until the study ends. The estimated study duration is approximately 4 years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 24 months, with additional annual long-term follow-up visits until the study's completion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06678841

ELEVATE-HFpEF Clinical Study

Recruiting
NAAges 40+InterventionalTreatment
Medtronic Cardiac Rhythm and Heart Failure
~700 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:Personalized cardiac pacing

At a glance

Recruiting sites
50 of 50 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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.
Measured over Follow-up duration for endpoint analysis is 12-months.
+1 more outcome measured

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF)

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

50 sites across 40 states
France3
United Kingdom3
Ohio2
Pennsylvania2
Texas2
Canada2
Hong Kong2
Malaysia2

Who to contact

Dawn Dyer
[email protected]
954-682-8334
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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).

What this trial measures

  • 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.