REmodeling the Left Ventricle With Atrial Modulated Pacing (NCT03210402) | Clinical Trial Compass
CompletedNot Applicable
REmodeling the Left Ventricle With Atrial Modulated Pacing
United States22 participantsStarted 2017-09-15
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 pr…