REmodeling the Left Ventricle With Atrial Modulated Pacing

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona - Sarver Heart Center, Tucson, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Elevated night pacing on

Device

Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times

Elevated night pacing off

Device

Device will be programmed to normal lower rates

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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Acronym: REVAMP

Important dates

Study start: 2017
Primary completion: 2021
Study completion: 2021
First posted: Jul 6, 2017
Registry last updated: Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed