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Clinical Trials in the UK / NCT06678841
Recruiting Not applicable

ELEVATE-HFpEF Clinical Study

NCT06678841 · tracked via the Priya Life Science UK tracker
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
Phase
Not applicable
Started
2025-07-09
Last updated
2026-08-03

Condition(s) studied

Heart Failure With Preserved Ejection Fraction (HFpEF)

Investigational drug(s) / intervention(s)

Personalized cardiac pacing

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

Study 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).

Eligibility

Sex
ALL
Min age
40 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 40 years 2. Documented EF ≥50% within the preceding 12 months 3. HFpEF defined as: 1. 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 2. 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).

Primary outcome measure(s)

Trial sites (50)

FacilityCityRegionStatus
Banner - University Medical Center Phoenix Phoenix Arizona Recruiting
Sutter Health Hospital San Francisco California Recruiting
Hartford Hospital Hartford Connecticut Recruiting
Cardiovascular Institute of Northwest Florida Panama City Florida Recruiting
Emory University Atlanta Georgia Recruiting
The University of Chicago Medical Center Chicago Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Norton Healthcare Louisville Kentucky Recruiting
Cardiovascular Institute of the South Houma Louisiana Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
M Health Fairview University of Minnesota Medical Center - East Bank Minneapolis Minnesota Recruiting
Saint Lukes Mid America Heart Institute Kansas City Missouri Recruiting
Duke University Medical Center Durham North Carolina Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Mount Carmel East Columbus Ohio Recruiting
Lancaster General Hospital Lancaster Pennsylvania Recruiting
Lankenau Institute for Medical Research Wynnewood Pennsylvania Recruiting
Medical University of South Carolina (MUSC) Charleston South Carolina Recruiting
Saint Thomas Research Institute Nashville Tennessee Recruiting
Dallas VA Medical Center Dallas Texas Recruiting
Texas Health Research & Education Institute Fort Worth Texas Recruiting
The University of Vermont Medical Center Burlington Vermont Recruiting
Inova Fairfax Hospital Falls Church Virginia Recruiting
Saint Joseph Medical Center (Tacoma WA) Tacoma Washington Recruiting
Charleston Area Medical Center (CAMC) Memorial Hospital Charleston West Virginia Recruiting
Froedtert Hospital Milwaukee Wisconsin Recruiting
The Prince Charles Hospital Chermside Queensland Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Ordensklinikum Linz GmbH / Elisabethinen Linz Austria Recruiting
Universitair Ziekenhuis Antwerpen Edegem Belgium Recruiting
University of Calgary Calgary Canada Recruiting
Saint Pauls Hospital Vancouver Canada Recruiting
Fakultni nemocnice Královské Vinohrady Prague Czechia Recruiting
Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz Besançon France Recruiting
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied Clermont-Ferrand France Recruiting
CHU Toulouse - Hôpital Rangueil Toulouse France Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck Germany Recruiting
Prince of Wales Hospital Hong Kong Hong Kong Recruiting
Queen Elizabeth Hospital (Hong Kong) Hong Kong Hong Kong Recruiting
Chiba University Hospital Chiba Chiba Recruiting

+ 10 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06678841 on ClinicalTrials.gov ↗ ← All trials in the UK