Testing Personalized cardiac pacing for heart failure with preserved ejection fraction (hfpef)
Official title: ELEVATE-HFpEF Clinical Study
Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)
Interventions
Personalized cardiac pacing
Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
Canadian Sites (2)
University of Calgary
Calgary, Canada
Saint Pauls Hospital
Vancouver, Canada
Eligibility Criteria
See who this study is looking for37 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 visitBaselineYour starting measurements, taken before treatment begins.Read more → 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
- +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 protocolProtocolThe detailed plan a study must follow.Read more → (e.g., patient is able to ambulate independently at baseline).
Exclusion
- −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))
- −Average heart rate \<50 bpm or symptomatic bradycardia
- −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
- −Known contraindication for a pacemaker implant
- −Advanced co-morbidity with life expectancy \< 1 year
- −Patients who are currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → 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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →).
- −Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
- −Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visitBaselineYour starting measurements, taken before treatment begins.Read more → or an elective PCI within 30 days prior to baseline visit.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
What is being given or done in this study: Personalized cardiac pacing.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
Neither you nor the study team would know which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment at all, and is followed for comparison.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists a minimum age of 40 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 700 people.
The study is currently expected to finish around February 2029.
The main measurement is taken over: Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → duration for endpointEndpointThe specific thing a study measures to answer its question.Read more → analysis is 12-months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Primary Efficacy Objective: Hierarchical composite endpointEndpointThe specific thing a study measures to answer its question.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more → duration for endpoint analysis is 12-months.
Primary Safety Objective: Percentage of patients with major complications related to the system or procedure — measured over 12-months post pacemaker implant attempt.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06678841 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Personalized cardiac pacingDevice
Personalized cardiac pacing treatment based each patient's height and baseline LVEF.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 40 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives no study treatment and is followed for comparison.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
Neither you nor the study team would know which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 40 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → duration for endpointEndpointThe specific thing a study measures to answer its question.Read more → analysis is 12-months..
The study as a whole is currently expected to finish around 2029-02.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 4 locations, including: Calgary, Canada; Vancouver, Canada; Minneapolis, Minnesota, United States; Tacoma, Washington, United States.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
Other Sites (2)
M Health Fairview University of Minnesota Medical Center - East Bank
Minneapolis, Minnesota, United States
Saint Joseph Medical Center (Tacoma WA)
Tacoma, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.