Vanderbilt Clinical Trials

REmodeling the Left Ventricle With Atrial Modulated Pacing

Purpose

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.

Condition

Heart Failure

Eligibility

Eligible Ages: Between 18 Years and 99 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Single (Participant)

Arm Groups

Arm	Description	Assigned Intervention
Active Comparator Elevated night pacing on		Device: Elevated night pacing on Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
Placebo Comparator Elevated night pacing off		Device: Elevated night pacing off Device will be programmed to normal lower rates

More Details

Status: Completed
Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.