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)

Am Heart J. 2019 Mar;209:1-8. doi: 10.1016/j.ahj.2018.12.004. Epub 2018 Dec 8.

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).

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

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

Associated data

  • ClinicalTrials.gov/NCT02006069