MOMENTUM 3 Pivotal Cohort Extended Follow-up Post-Approval Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Subject outcomes and survival
研究概览
简要总结
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.
详细描述
Subjects on LVAD support after the MOMENTUM 3 IDE trial 2-year follow-up visit can be enrolled after providing consent to extended follow-up. They will be followed to 5 years post-implant or outcome (transplant, explant or death), whichever occurs first.
Subjects who have been transplanted, their device exchanged to another pump other than a HM II or HM3, or explanted after the MOMENTUM 3 IDE trial 2-year follow-up but prior to providing consent for this PAS can also be enrolled. Data between the 2-year follow-up visit and the date of pump exchange, explant, or transplant will be retrospectively collected.
Once enrolled, if subjects receive a device exchange to any device other than HM II or HM3, at any time during the study, they will be withdrawn from the study and will not be followed.
In the event that a subject expired prior to providing consent, IRB approval will be obtained to collect the date and cause of death.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or legal representative has signed Informed Consent Form (ICF)
- •Subject was enrolled in the MOMENTUM 3 IDE trial and was ongoing at the 2-year follow-up visit
排除标准
- •Subject or legal representative does not consent to extended data collection after the MOMENTUM 3 IDE trial 2-year follow-up visit
- •Special Circumstance:
- •Sites with patients who expired after the MOMENTUM 3 IDE trial 2-year follow-up visit but prior to signing the ICF for this PAS will obtain IRB approval to collect only the date and cause of death
结局指标
主要结局
Subject outcomes and survival
时间窗: up to 5 years post-implant
Subject outcomes and survival which includes death, transplant, explant, or a pump exchange to any device other than HM II or HM3
Neurological dysfunction
时间窗: up to 5 years post-implant
Frequency and incidence of neurological dysfunction
Major infection
时间窗: up to 5 years post-implant
Frequency and incidence of major infection
6MWD
时间窗: up to 5 years post-implant
Six-minute walk distance (6MWD)
Survival
时间窗: up to 5 years post-implant
Composite of Survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score \> 3) or reoperation to replace the pump
Bleeding (including GI bleeding)
时间窗: up to 5 years post-implant
Frequency and incidence of bleeding (including GI bleeding)
Hemolysis
时间窗: up to 5 years post-implant
Frequency and incidence of hemolysis
Device thrombosis
时间窗: up to 5 years post-implant
Frequency and incidence of device thrombosis
NYHA
时间窗: up to 5 years post-implant
New York Heart Association (NYHA) classification
Device related SAEs
时间窗: up to 5 years post-implant
Frequency and incidence of device related SAEs
次要结局
未报告次要终点