NCT03210402CompletedNot Applicable
REmodeling the Left Ventricle With Atrial Modulated Pacing
Medtronic Cardiac Rhythm and Heart Failure20 sites in 1 country22 target enrollmentStarted: September 15, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 22
- Locations
- 20
- Primary Endpoint
- Number of Participants Who Remained on Study
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- 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 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 <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 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
Outcomes
Primary Outcomes
Number of Participants Who Remained on Study
Time Frame: Baseline through 12 week follow-up
REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (20)
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