REmodeling the Left Ventricle With Atrial Modulated Pacing

Study Overview
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Brief Summary
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New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.

Official Title
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REmodeling the Left Ventricle With Atrial Modulated Pacing

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Elevated night pacing on
* Device: Elevated night pacing off


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 3 months Subject is stable on current medications Subject has dyspnea with exertion or diagnosed as NYHA Class II or III Heart Failure Subject has had a prior Echo in past 6 months with: EF ≥ 50% and Diastolic volume <80 ml/m² Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women 95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall thickness >0.42, or Wall Thickness>1.2cm (posterior wall) Subject is willing to sign and date the study Informed Consent Form (IC Form) - Subject is 18 years of age or older, or of legal age to give informed consent per local law Subject is expected to remain available for follow-up visits Exclusion Criteria: Subject has permanent AF or AF noted on baseline interrogation rhythm strip Subject has uncontrolled BP; (systolic pressure needs to be >100mmHg and <160mmHg on medications) Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0 cm² or severe regurgitation of the aortic or mitral valve Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen Subject's Pacemaker has less than 6 months of Pacemaker battery life Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9 months prior to enrollment Subject's programmed upper rate limit is less than 100 bpm because of concerns of elevated pacing Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled study visits Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager) Subject is pregnant Subject meets any exclusion criteria required by local law Subject's life expectancy is less than 12 weeks Subject with medical condition that precludes the patient from participation in the opinion of the investigator Subject has known coronary disease with Class II angina

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Elevated night pacing on<br> | Device: Elevated night pacing on<br>* Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times<br>|
| Placebo Comparator: Elevated night pacing off<br> | Device: Elevated night pacing off<br>* Device will be programmed to normal lower rates<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant's Ability to Tolerate Therapy | Participant's Ability to Tolerate Night Heart Pacing. The outcome of interest is the proportion of subjects who remain in the study. Study exit reasons will include intolerable symptoms, increase in NT-proBNP levels, decrease in LVEF or increase in troponin. The proportion of subjects remaining in study will be calculated along with the lower bound of the one-sided 95% confidence interval. | Baseline through 12 week follow-up |