Rationale and design of a randomized clinical trial to assess the safety and efficacy of multipoint pacing therapy: MOre REsponse on Cardiac Resynchronization Therapy with MultiPoint Pacing (MORE-CRT MPP–PHASE II)

• Published in: The American heart journal Vol. 209; pp. 1 - 8
• Main Authors: Leclercq, Christophe, Burri, Haran, Curnis, Antonio, Delnoy, Peter Paul, Rinaldi, Christopher A, Sperzel, Johannes, Lee, Kwangdeok, Cohorn, Clay, Thibault, Bernard
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2019; Elsevier Limited; Elsevier
• Subjects: Aged; Bioengineering; Cardiac Resynchronization Therapy - methods; Cardiology; Cardiology and cardiovascular system; Classification; Clinical trials; Congestive heart failure; Engineering Sciences; Enrollments; Female; Follow-Up Studies; Heart; Heart failure; Heart Failure - physiopathology; Heart Failure - therapy; Human health and pathology; Humans; Life Sciences; Male; Patients; Prospective Studies; Questionnaires; Signal and Image processing; Stroke Volume - physiology; Therapy; Time Factors; Transplants & implants; Treatment Outcome; Ultrasonic imaging; Ventricle; Ventricular Function, Left - physiology; Ventricular Remodeling; biventricular pacing; heart failure; multipoint pacing; cardiac resynchronization; left ventricular lead; randomized trial
• ISSN: 0002-8703; 1097-6744; 1097-6744
• DOI: 10.1016/j.ahj.2018.12.004

Although cardiac resynchronization therapy (CRT) is beneficial in most heart failure patients, up to 40% do not respond to CRT. Data from the MultiPoint Pacing (MPP) IDE trial and MORE-CRT MPP–PHASE I study suggest improved response in subjects in the MPP arm—programmed with wide left ventricular (LV) electrode anatomical separation (≥30 mm) and shortest timing delays of 5 milliseconds (MPP-AS)—compared with quadripolar biventricular (BiV) pacing. The MORE-CRT MPP–PHASE II trial is a prospective, randomized, multicenter study to assess the 6-month impact of MPP programmed to mandated MPP-AS settings in subjects who do not respond to 6 months of BiV pacing (MPP OFF). Approximately 5,000 subjects with a standard CRT indication will be enrolled and implanted with a quadripolar CRT system (Abbott) capable of delivering MPP. Only BiV pacing is activated at implant. At 6 months, subjects classified as CRT nonresponders (<15% reduction in LV end-systolic volume) are randomized (1:1) to MPP or continued BiV pacing. The mandated MPP parameters (eg, MPP-AS) are programmed to subjects randomized to the MPP arm. At 12 months, the 2 groups will be compared to determine if there is a difference in CRT response rate. This trial will evaluate whether MPP programmed to mandated MPP-AS settings improves LV reverse remodeling and clinical response to CRT in patients who fail to respond to 6 months of BiV pacing (www.clinicaltrials.gov identifier NCT02006069).