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).

Abstract

BACKGROUND:

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.

STUDY DESIGN:

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.

CONCLUSIONS:

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).

• Authors: Christophe Leclercq, Haran Burri, Antonio Curnis, Peter Paul Delnoy, Christopher A Rinaldi, Johannes Sperzel, Kwangdeok Lee, Clay Cohorn, Bernard Thibault, MORE-CRT MPP Investigators
• Journal: American heart journal (Am Heart J) Vol. 209 Pg. 1-8 (03 2019) ISSN: 1097-6744 [Electronic] United States
• PMID: 30616009 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2018 Elsevier Inc. All rights reserved.

Topics

• Aged
• Cardiac Resynchronization Therapy (methods)
• Female
• Follow-Up Studies
• Heart Failure (physiopathology, therapy)
• Humans
• Male
• Prospective Studies
• Stroke Volume (physiology)
• Time Factors
• Treatment Outcome
• Ventricular Function, Left (physiology)
• Ventricular Remodeling