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REmodeling the Left Ventricle With Atrial Modulated Pacing (REVAMP)

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ClinicalTrials.gov Identifier: NCT03210402
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm and Heart Failure

Tracking Information
First Submitted Date  ICMJE February 27, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE September 15, 2017
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03210402 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE REmodeling the Left Ventricle With Atrial Modulated Pacing
Official Title  ICMJE REmodeling the Left Ventricle With Atrial Modulated Pacing
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Heart Failure
Intervention  ICMJE
  • Device: Elevated night pacing on
    Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
  • Device: Elevated night pacing off
    Device will be programmed to normal lower rates
Study Arms  ICMJE
  • Active Comparator: Elevated night pacing on
    Intervention: Device: Elevated night pacing on
  • Placebo Comparator: Elevated night pacing off
    Intervention: Device: Elevated night pacing off
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2018)
50
Original Estimated Enrollment  ICMJE
 (submitted: July 5, 2017)
40
Estimated Study Completion Date  ICMJE April 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: REVAMP Clinical Study Manager 1-800-328-2518 medtronicCRMtrials@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03210402
Other Study ID Numbers  ICMJE REVAMP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Medtronic Cardiac Rhythm and Heart Failure
Study Sponsor  ICMJE Medtronic Cardiac Rhythm and Heart Failure
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: David Steinhaus, MD Medtronic CRHF
PRS Account Medtronic Cardiac Rhythm and Heart Failure
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP