ELEVATE-HFpEF Clinical Study

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join 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
• 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).

🚫 You may not be able to join 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
• 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).

Where this trial is running

• Banner - University Medical Center Phoenix, Phoenix, Arizona, United States
• Sutter Health Hospital, San Francisco, California, United States
• Hartford Hospital, Hartford, Connecticut, United States
• Cardiovascular Institute of Northwest Florida, Panama City, Florida, United States
• Emory University, Atlanta, Georgia, United States
• The University of Chicago Medical Center, Chicago, Illinois, United States
• University of Kansas Medical Center, Kansas City, Kansas, United States
• Norton Healthcare, Louisville, Kentucky, United States
• Cardiovascular Institute of the South, Houma, Louisiana, United States
• Tufts Medical Center, Boston, Massachusetts, United States
• M Health Fairview University of Minnesota Medical Center - East Bank, Minneapolis, Minnesota, United States
• Saint Lukes Mid America Heart Institute, Kansas City, Missouri, United States

+ 34 more sites.

Who to contact

Dawn Dyer · 954-682-8334 · dawn.dyer@medtronic.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06678841.