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REVAMP: REmodeling the Left Ventricle With Atrial Modulated Pacing

Sponsor
Medtronic Cardiac Rhythm and Heart Failure (Industry)
Overall Status
Completed
CT.gov ID
NCT03210402
Collaborator
(none)
22
Enrollment
10
Locations
2
Arms
42
Actual Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Elevated night pacing on
  • Device: Elevated night pacing off
 N/A

Study Design

Study Type:
Interventional
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 :
Sep 15, 2017
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Mar 15, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Participant's Ability to Tolerate Therapy [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

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
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 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

Locations

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

Sponsors and Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Investigators

  • Study Director: David Steinhaus, MD, Medtronic CRHF

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Medtronic Cardiac Rhythm and Heart Failure
ClinicalTrials.gov Identifier:
NCT03210402
Other Study ID Numbers:
  • REVAMP
First Posted:
Jul 6, 2017
Last Update Posted:
Apr 19, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of Apr 19, 2021