Individualized Pacemaker Programming for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method of programming pacemakers for individuals with heart failure who maintain normal heart pumping ability (preserved ejection fraction). The goal is to personalize pacemaker settings to enhance participants' exercise capacity, well-being, and daily functioning. Participants must have an existing pacemaker and experience heart failure symptoms that impact daily life despite ongoing treatment. The study will compare standard pacemaker settings with a personalized approach, known as Individualized myPACE pacemaker programming, over time. As an unphased trial, it offers participants the chance to contribute to innovative research that could improve the quality of life for those with heart failure.
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing heart failure treatments, as the study involves personalized pacemaker programming rather than medication changes.
What prior data suggests that this pacemaker programming is safe for heart failure patients?
Studies have shown that personalized pacemaker programming, such as myPACE, is generally well-tolerated by individuals with heart failure with preserved ejection fraction (HFpEF). Research indicates that this type of pacing does not cause significant side effects. Participants in earlier studies reported improvements in quality of life and physical activity levels.
Although specific data on serious side effects is lacking, the absence of negative reports in these studies suggests the treatment is safe for most people. However, as with any medical treatment, individual experiences may vary, and discussing any concerns with a healthcare provider is important.12345Why are researchers excited about this trial?
Researchers are excited about individualized myPACE pacemaker programming because it offers a tailored approach to managing heart failure. Unlike the standard pacemaker settings, which typically have a fixed lower rate limit, myPACE adjusts the heart rate dynamically based on each patient’s unique needs. This personalized pacing could potentially improve heart function and quality of life by optimizing heart rate in real-time, rather than relying on a one-size-fits-all setting. This innovative approach aims to provide more effective management of heart failure symptoms, making it a promising advancement in cardiac care.
What evidence suggests that individualized myPACE pacemaker programming is effective for heart failure with preserved ejection fraction?
Research has shown that the myPACE pacemaker, personalized for each patient, could help people with heart failure with preserved ejection fraction (HFpEF) live better. Studies have found that it can improve quality of life, increase physical activity, and reduce irregular heartbeats. Patients have also exercised more without getting tired. Early evidence suggests this approach might improve heart function and lead to fewer hospital visits. Overall, personalized pacing appears promising for those with HFpEF.12467
Who Is on the Research Team?
Margaret Infeld, MD, MS
Principal Investigator
Tufts Medical Center
Are You a Good Fit for This Trial?
This trial is for people who have heart failure with preserved ejection fraction (HFpEF) and already have a special type of pacemaker. Participants should be able to take part in exercise and health assessments.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Participants undergo a 3-month baseline period with pacemaker programmed to standard-of-care settings
Treatment
Participants receive individualized programming using the myPACE heart-rate algorithm
Reprogramming
Pacemakers are reprogrammed to standard-of-care settings for an additional 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Individualized myPACE pacemaker programming
Trial Overview
The study tests whether adjusting each person's pacemaker settings (myPACE) can improve their heart function, exercise ability, and quality of life compared to standard pacemaker programming. Each participant tries both approaches during the study.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will undergo a 3-month baseline period with their pacemaker programmed to standard-of-care settings (lower rate limit of 60 beats per minute), followed by individualized programming using the myPACE heart-rate algorithm for 12 months. Following completion of the 12-month intervention period, pacemakers will be reprogrammed to standard-of-care settings (60 bpm) for an additional 3 months. Participants will undergo study assessments and monitoring throughout the entire 18-month study period.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Citations
1.
experts.umn.edu
experts.umn.edu/en/publications/rationale-and-design-of-the-pace-hfpef-trial-physiologic-accelera/Rationale and design of the PACE HFpEF trial: Physiologic ...
having shown improvements in quality of life, natriuretic peptide and activity levels, and atrial fibrillation burden.
Effect of Personalized Accelerated Pacing on Quality of Life ...
Effect of Personalized Accelerated Pacing on Quality of Life, Physical Activity, and Atrial Fibrillation in Patients With Preclinical and ...
3.
xtalks.com
xtalks.com/how-medtronics-global-heart-failure-trial-explores-personalized-pacing-for-hfpef-4546/How Medtronic's Global Heart Failure Trial Explores ...
Robert Kowal discusses how Medtronic's ELEVATE-HFpEF heart failure trial is investigating personalized cardiac pacing.
Clinical Outcomes With Personalized Accelerated ...
Clinical Outcomes With Personalized Accelerated Physiologic Pacing in HFpEF. JAMA Cardiology Author Interviews. Aug 27, 2025. 20 min.
Potential Prevention of Pacing‐Induced Heart Failure Using ...
This study was designed to test the hypothesis that specific DDDR pacemaker programming may influence patients' exercise tolerance, ...
6.
researchgate.net
researchgate.net/publication/398781844_Long-Term_Outcomes_Beta-Blocker_Use_and_Permanent_Pacing_in_Patients_With_Heart_Failure_Preserved_Ejection_FractionBeta-Blocker Use and Permanent Pacing in Patients With ...
Objectives The purpose of this study was to evaluate the long-term outcomes of pacing and therapy with beta-blockers in patients with HFpEF. Methods In this ...
7.
biospace.com
biospace.com/press-releases/medtronic-initiates-global-pivotal-study-of-cardiac-pacing-in-a-new-patient-populationMedtronic initiates global pivotal study of cardiac pacing in ...
Earlier clinical studies have suggested that personalized elevated pacing rates could positively impact patient outcomes for those with HFpEF ...
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