REmodeling the Left Ventricle With Atrial Modulated Pacing (REVAMP)

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Elevated night pacing on; Device: Elevated night pacing off

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724-0001
      • University of Arizona - Sarver Heart Center
  • California
    • Stockton, California, United States, 95204-6019
      • St Joseph's Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60611-2969
      • Northwestern University
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Medical Center Fairview
  • New Jersey
    • Voorhees, New Jersey, United States, 08043-4322
      • Lourdes Cardiology Services
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2906
      • The Lindner Research Center
    • Columbus, Ohio, United States, 43210-1240
      • The Ohio State University Wexner Medical Center
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Lancaster General Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425-8905
      • Medical University of South Carolina (MUSC)
  • Tennessee
    • Nashville, Tennessee, United States, 37212-2717
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Remained on Study	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.	Baseline through 12 week follow-up

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Study Director: David Steinhaus, MD, Medtronic CRHF

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): March 15, 2021
• Study Completion (Actual): March 15, 2021

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 11, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: REVAMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes