ELEVATE-HFpEF study
Research type
Research Study
Full title
Randomized trial of ELEVATEd cardiac pacing rate for personalized treatment of Heart Failure with preserved Ejection Fraction
IRAS ID
357466
Contact name
Klaus Witte
Contact email
Sponsor organisation
Medtronic, Bakken Research Center
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
The purpose of this study is to evaluate the safety and efficacy of dual chamber pacing where the pacemaker’s lower rate is set to a personalized rate based on a patient’s left ventricle ejection fraction (LVEF) and height, compared to minimal or no pacing, for the treatment of heart failure with preserved ejection fraction HFpEF.
LVEF is a measurement that will be taken from an echocardiogram (a test that uses sound waves to check how well the heart pumps blood).
For this study, the patient will receive a Medtronic pacemaker. Pacemakers are used to regulate heart rates that are too slow in other patient groups, however, it is not yet known whether using a pacemaker to speed up slow heart rates is safe and effective to improve symptoms in HFpEF patients.
Patients in this study will be assigned (randomized) to one of two study groups
Group 1,The pacemaker will be programmed to pace heart at a personalized rate that is unique to the patients height and left ventricle ejection fraction (LVEF) measurement from their echocardiogram. The pacemaker will have the same programming (to pace the heart at a personalized rate) for the duration of the study.
Group 2: The pacemaker will be programmed to pace the heart at a rate that is not personalized to the patient.
Medtronic market-approved dual chamber Implantable Pulse Generators (IPGs) and MRI SureScan leads will be used in the clinical study. All products will be used according to the corresponding product instructions for use (IFU), but will be considered investigational as the products will be used outside of the currently approved patient indication.
The software in this study is investigational and will be installed on market released Medtronic CareLink SmartSyncTM Programmer Systems.
Up to 700 subjects will be enrolled in this study at up to 75 sites worldwide. participation in the study will be at least 18 months and will end when the overall study ends. The overall study is expected to last approximately 4.5 years.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0155
Date of REC Opinion
26 Aug 2025
REC opinion
Further Information Favourable Opinion