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ELEVATE-HFpEF Clinical Study

NARECRUITING

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).

Study details:

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 lower rate of 30 bpm 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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Age ≥ 40 years
  2. Documented EF ≥50% within the preceding 12 months
  3. 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
  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)

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT06678841

Intervention or treatment

DEVICE: Personalized cardiac pacing

Conditions

  • Heart Failure With Preserved Ejection Fraction (HFpEF)

  • Condition: Heart Failure With Preserved Ejection Fraction (HFpEF)

  • DEVICE: Personalized cardiac pacing

  • Chermside, Queensland, Australia and more

  • Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

The Prince Charles Hospital

Select from list below to view details:

  • The Prince Charles Hospital

    Chermside, Queensland, Australia

  • The Alfred Hospital

    Melbourne, Victoria, Australia

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Who is running the clinical trial?

MCRaHF

Medtronic Cardiac Rhythm and Heart Failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Personalized Pacing Therapy (Treatment Group)
  • 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
    NO_INTERVENTION: Control Group
    • 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.

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      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 Outcome

      MeasureDescriptionTime Frame
      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.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.NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups.Follow-up duration for endpoint analysis is 12-months.
      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.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.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.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.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.Follow-up duration for endpoint analysis is 12-months.
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: ELEVATE-HFpEF Clinical Study

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