REmodeling the Left Ventricle With Atrial Modulated Pacing

Medtronic Cardiac Rhythm and Heart Failure10 sites in 1 country22 target enrollmentSeptember 15, 2017

ConditionsHeart Failure

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Failure
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Enrollment: 22
Locations: 10
Primary Endpoint: Number of Participants Who Remained on Study
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2017

End Date

March 15, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Responsible Party

Sponsor

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 \<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

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.