Personalized Cardiac Pacing for Heart Failure

(ELEVATE-HFpEF Trial)

Recruiting at 8 trial locations

Overseen By Dawn Dyer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Must be taking: Loop diuretics

Disqualifiers: Pregnancy, Severe obesity, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

700 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to improve symptoms in people with heart failure using personalized cardiac pacing, a specialized pacemaker setting. It compares two groups: one receives a personalized pacemaker setting based on height and heart function, while the other receives a standard setting. The trial aims to determine if the personalized approach benefits those with heart failure with preserved ejection fraction, where the heart pumps normally but is stiff when relaxed. This trial may suit individuals who have experienced heart failure symptoms for some time and use medication for management. As an unphased trial, it provides a unique opportunity to explore innovative treatments that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you must be on stable heart failure medication for at least 30 days before joining the trial.

What prior data suggests that personalized cardiac pacing is safe for heart failure patients?

Research has shown that personalized heart pacing is generally well-tolerated. Studies have found that adjusting pacemakers to meet a patient's specific needs can improve heart failure symptoms and enhance exercise capacity. Although specific safety data is not available, this treatment uses existing pacemaker technology, which is widely approved and considered safe. Regular pacing in the right side of the heart can sometimes cause irregular heartbeats and heart failure. Personalized pacing aims to reduce these issues by customizing the pacing for each patient. Overall, this personalized approach is designed to be safer and more effective than standard pacing. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Personalized Cardiac Pacing for heart failure because it offers a tailored approach that could improve patient outcomes. Unlike traditional pacemakers that use a one-size-fits-all pacing rate, this treatment customizes the pacing rate based on a patient's height and baseline left ventricular ejection fraction (LVEF). This personalization might enhance heart function more effectively and provide better symptom relief compared to standard pacing methods. By addressing the unique cardiac needs of each patient, this method has the potential to optimize heart performance more precisely than existing options.

What evidence suggests that personalized cardiac pacing is effective for heart failure with preserved ejection fraction?

This trial will compare personalized cardiac pacing with standard pacing for heart failure patients. Studies have shown that personalized cardiac pacing can enhance the quality of life for those with heart failure. In the myPACE study, patients reported feeling better and found daily activities easier, as measured by the Minnesota Living with Heart Failure Questionnaire. Another study found similar improvements using the Kansas City Cardiomyopathy Questionnaire, which assesses the impact of heart disease on daily life. Personalized pacing adjusts the heart's rhythm to fit individual needs, effectively managing heart failure symptoms. These findings suggest that this approach can significantly benefit patients. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

The ELEVATE-HFpEF study is for adults over 40 with heart failure who have preserved ejection fraction (HFpEF). Participants must have had a worsening heart failure episode in the past year or meet specific criteria like certain levels of NT-proBNP, pulmonary capillary wedge pressure, and left ventricular mass. They should not be part of this trial if they don't meet these detailed heart-related measurements.

Inclusion Criteria

My heart's wall thickness is 0.42 or more.

I am 40 years old or older.

My NT-proBNP levels were above normal in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Implantation

Baseline data collection and pacemaker implantation

1-2 weeks

1 visit (in-person)

Randomization and Initial Treatment

Participants are randomized to treatment or control group and begin pacing therapy

12 months

3 visits (in-person) at 2, 6, and 12 months

Extended Treatment

Control group receives personalized pacing; continued data collection

12 months

3 visits (in-person) at 14, 18, and 24 months

Long-term Follow-up

Annual follow-up visits to monitor long-term outcomes

Annually until study completion

What Are the Treatments Tested in This Trial?

Interventions

• Personalized Cardiac Pacing

Trial Overview This clinical trial tests personalized cardiac pacing against minimal or no pacing to see which is better for treating HFpEF. Patients are randomly assigned to one of the two groups without knowing which group they're in, and researchers compare the outcomes between these groups.

How Is the Trial Designed?

Group I: Personalized Pacing Therapy (Treatment Group) Experimental Treatment 1 Intervention

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.

Group II: Control Group Active Control 1 Intervention

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 non-personalized rate. This is considered limited or backup pacing.

Who Is Running the Clinical Trial?

Medtronic Cardiac Rhythm and Heart Failure

Lead Sponsor

Trials

206

Recruited

137,000+

Geoff Martha

Medtronic Cardiac Rhythm and Heart Failure

Chief Executive Officer since 2020

MBA from University of Minnesota

Dr. Kweli Thompson

Medtronic Cardiac Rhythm and Heart Failure

Chief Medical Officer since 2022

MD from Harvard Medical School

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9996402/

Effect of Personalized Accelerated Pacing on Quality of Life ... The primary outcome of the myPACE study was the change in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline.

2. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2023/03/03/15/52/mypace

Personalized Pacing: A New Paradigm for Patients With ... The goal of the trial was to assess the safety and efficacy of a personalized accelerated pacing algorithm in patients with heart failure and ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.123.032873

Effects of Continuous Accelerated Pacing on Cardiac ... In addition, heart failure‐related quality of life as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score improved by 2.4 ...

4. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(23)02026-X/fulltext

2023 HRS/APHRS/LAHRS guideline on cardiac ... Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019; 105:137-143. Crossref.

5. academic.oup.com academic.oup.com/eurheartjsupp/article/25/Supplement_G/G33/7394244

Personalized accelerated physiologic pacing - Oxford Academic With a lower rate setting of 60 b.p.m., 11 patients had 17 adverse events, most of them heart failure and AF-related. Since most participants ...

6. jacc.org jacc.org/doi/10.1016/j.jacc.2024.01.036

Effect of Personalized Accelerated Pacing in Patients With ... Personalized accelerated pacing for 3 months improves heart failure related health status, exercise capacity, and reduces left atrial volume.

7. heartrhythmjournal.com heartrhythmjournal.com/article/S1547-5271(24)03270-3/fulltext

Conduction system pacing associated with reduced ... Long-term RV pacing is associated with higher incidence of atrial fibrillation, heart failure, and mortality. Therapeutic pacing delivery using ...

8. prnewswire.com prnewswire.com/news-releases/medtronic-initiates-global-pivotal-study-of-cardiac-pacing-in-a-new-patient-population-302555905.html

Medtronic initiates global pivotal study of cardiac pacing in ... Study to evaluate whether a new approach to pacing the heart can improve the lives of patients with heart failure with preserved ejection ...