Clinical trial NCT03210402: REmodeling the Left Ventricle With Atrial Modulated Pacing
Official title: REmodeling the Left Ventricle With Atrial Modulated Pacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 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

Primary outcomes:
measure: Number of Participants Who Remained on Study
timeFrame: Baseline through 12 week follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona - Sarver Heart Center
state: Arizona
city: Stockton
country: United States
facility: St Joseph's Medical Center
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Cincinnati
country: United States
facility: The Lindner Research Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina (MUSC)
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Medtronic CRHF
name: David Steinhaus, MD
role: STUDY_DIRECTOR
References: