Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• 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).

Locations
United States
Georgia
Emory University
RECRUITING
Atlanta
Louisiana
Cardiovascular Institute of the South
RECRUITING
Houma
Ohio
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Other Locations
Australia
The Prince Charles Hospital
RECRUITING
Chermside
The Alfred Hospital
RECRUITING
Melbourne
Contact Information
Primary
Dawn Dyer
dawn.dyer@medtronic.com
954-682-8334
Time Frame
Start Date: 2025-07-09
Estimated Completion Date: 2029-02
Participants
Target number of participants: 700
Treatments
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.
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 lower rate of 30 bpm. This is considered limited or backup pacing.
Sponsors
Leads: Medtronic Cardiac Rhythm and Heart Failure

This content was sourced from clinicaltrials.gov