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) - 17/03/19
, Haran Burri, MD b, Antonio Curnis, MD, PhD c, Peter Paul Delnoy, MD, PhD d, Christopher A Rinaldi, MD, PhD e, Johannes Sperzel, MD, PhD f, Kwangdeok Lee, PhD g, Clay Cohorn g, Bernard Thibault, MD, PhD hon behalf of the MORE-CRT MPP Investigators
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).
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| RCT# NCT02006069 |
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| Funding: This study is sponsored by Abbott (ClinicalTrials.gov Identifier: NCT02006069). |
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| Author disclosure: Dr Leclercq has received honoraria from Abbott, Medtronic, Boston Scientific, Biotronik, and Livanova. Dr Burri has received institutional fellowship support and research grants from Abbott. Dr Curnis has received honoraria from Abbott, Medtronic, Boston Scientific, Biotronik, Livanova, and Spectranetics. Dr Delnoy serves as a consultant to Abbott. Dr Rinaldi has received research grants and honoraria from Abbott. Dr Sperzel serves as a consultant to Abbott, in addition to receiving honoraria and currently conducting research sponsored by Abbott. Lee and Cohorn are employees of Abbott. Dr Thibault has received research support and honoraria from Abbott and Medtronic. |
Vol 209
P. 1-8 - mars 2019 Retour au numéro
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