REmodeling the Left Ventricle With Atrial Modulated Pacing

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT03210402

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

22

Starts

2017-09-15

Expected to finish

2021-03-15

Last updated by the study team

2024-10-08

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arizona - Sarver Heart Center — Tucson, Arizona, United States
• St Joseph's Medical Center — Stockton, California, United States
• Northwestern University — Chicago, Illinois, United States
• University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• The Lindner Research Center — Cincinnati, Ohio, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Medical University of South Carolina (MUSC) — Charleston, South Carolina, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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