N/A N=14 Randomized Single-blind Treatment

REmodeling the Left Ventricle With Atrial Modulated Pacing

Heart Failure

Bottom Line

View on ClinicalTrials.gov: NCT03210402 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Oct 2024

Primary outcome: Primary: Number of Participants Who Remained on Study — 9; 4 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Elevated night pacing on (Device); Elevated night pacing off (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Who Remained on Study	9; 4	—

Summary

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.

Eligibility Criteria

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 New York Heart Association (NYHA) Class II or III Heart Failure
Subject has had a prior Echo in past 6 months with: Ejection Fraction (EF) ≥ 50% and Diastolic volume 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 atrial fibrillation (AF) or AF noted on baseline interrogation rhythm strip
Subject has uncontrolled BP; (systolic pressure needs to be >100 mmHg and <160 mmHg 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03210402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.