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REmodeling the Left Ventricle With Atrial Modulated Pacing (REVAMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210402
Recruitment Status : Completed
First Posted : July 6, 2017
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: Elevated night pacing on Device: Elevated night pacing off Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: REmodeling the Left Ventricle With Atrial Modulated Pacing
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Participant's Ability to Tolerate Therapy [ Time Frame: Baseline through 12 week follow-up ]
    Participant's Ability to Tolerate Night Heart Pacing. The outcome of interest is the proportion of subjects who remain in the study. Study exit reasons will include intolerable symptoms, increase in NT-proBNP levels, decrease in LVEF or increase in troponin. The proportion of subjects remaining in study will be calculated along with the lower bound of the one-sided 95% confidence interval.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210402


Locations
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United States, Arizona
University of Arizona - Sarver Heart Center
Tucson, Arizona, United States, 85724-0001
United States, California
St Joseph's Medical Center
Stockton, California, United States, 95204-6019
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611-2969
United States, Minnesota
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, United States, 55455
United States, New Jersey
Lourdes Cardiology Services
Voorhees, New Jersey, United States, 08043-4322
United States, Ohio
The Lindner Research Center
Cincinnati, Ohio, United States, 45219-2906
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210-1240
United States, Pennsylvania
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States, 29425-8905
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-2717
Sponsors and Collaborators
Medtronic Cardiac Rhythm and Heart Failure
Investigators
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Study Director: David Steinhaus, MD Medtronic CRHF
More Information
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Responsible Party: Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier: NCT03210402    
Other Study ID Numbers: REVAMP
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases