Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37212-2717
Contact:
Sherry Bowman

More Details

NCT ID
NCT03210402
Status
Recruiting
Sponsor
Medtronic Cardiac Rhythm and Heart Failure

Study Contact

REVAMP Clinical Study Manager
1-800-328-2518
medtronicCRMtrials@medtronic.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.