The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the MOMENTUM 3 IDE trial. A total of 1028 subjects were enrolled in the MOMENTUM 3 IDE trial. Approximately 533 subjects were ongoing support at the 2-year follow-up and are eligible for enrollment in this PAS. This study will be conducted at sites that participated in the MOMENTUM 3 IDE trial which will include up to 69 centers in the United States.
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Survival
Timeframe: up to 5 years post-implant
Subject outcomes and survival
Timeframe: up to 5 years post-implant
Bleeding (including GI bleeding)
Timeframe: up to 5 years post-implant
Major infection
Timeframe: up to 5 years post-implant
Hemolysis
Timeframe: up to 5 years post-implant
Device thrombosis
Timeframe: up to 5 years post-implant
Neurological dysfunction
Timeframe: up to 5 years post-implant
Device related SAEs
Timeframe: up to 5 years post-implant
NYHA
Timeframe: up to 5 years post-implant
6MWD
Timeframe: up to 5 years post-implant