Prospective REgistry to Study Clinical OutcomEs of Repair of Mitral ValvEs in South Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- All Cause Mortality
研究概览
简要总结
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
详细描述
There is limited local evidence on mitral repair products in South Asia and a prospective post market registry will provide real world data on clinical outcomes.
Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings will be considered for study participation.
PRESERVE-Mitral Registry is a prospective non-randomized, non-interventional, post-market registry
The objective of this registry is to gather data on the clinical outcomes of Medtronic mitral repair products (Profile 3D™ and CG Future® annuloplasty systems) in the approved intended use up to 12 months from the day of procedure
This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trail was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Heath Service Act or 42 CRF 11.24 and 11.44.)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with valvular insufficiency and/or stenosis and indicated for the reconstruction and/or remodeling of pathological mitral valves with Profile 3D™ and CG Future® annuloplasty systems
- •Indications and contraindications provided in the product Instructions for Use
- •Subject is 18 years of age or older
- •The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the registry and the patient informed consent for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements
排除标准
- •Contraindications as per instructions-for-use (IFU):
- •Heavily calcified valves
- •Valvular retraction with severely reduced mobility
- •Active bacterial endocarditis
- •Aortic valve replacement as concomitant procedure
- •Already participating in another clinical study, possibly leading to bias and jeopardizing the scientific appropriate assessment of the study endpoints
结局指标
主要结局
All Cause Mortality
时间窗: 12 months
All deaths occurring from any cause 12-months post procedure
Improvement in Mitral Regurgitation (MR) Grade at 12-months Post Procedure
时间窗: 12 months
This is determined by assessing the level of mitral valve regurgitation using echo, in subjects at 12-months post-procedure compared to the level at baseline. The levels of regurgitation, level 0-4, correspond to the American Society of Echocardiography (ASE) guidelines ranging from no MR, Mild MR, Moderate MR, Moderate- to-Severe MR and Severe MR. A percentage number is calculated to reflect how many participants had an MR improvement.
次要结局
- Total Bypass Time During the Implant Procedure(During the procedure as measured by standard operating procedures at the sites)
- Hospitalization for Heart Failure at 6 Months and at 12 Months Post Procedure(6 months and 12 months post procedure)
- Improvement in NYHA Functional Class at Discharge, First Follow-up (3-6 Months) and Second Follow-up (12-months) Compared to Baseline.(At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months))
- Stroke at 6 Months and at 12 Months Post Procedure(6 months and 12 months post procedure)
- Number of Attempts Required for Procedural Success(Procedure (defined as the date of the first attempted procedure through subject leaving the operating theater with an implanted Profile 3D or CG Future annuloplasty system))
- Percentage of Participants With Improvement in MR Grade at Discharge and First Follow-up (3-6 Months)(At discharge from hospital (up to 7 days) and at first follow-up (3-6month))
- Mitral Valve Re-intervention at Discharge, 6 Months and at 12 Months Post Procedure(At discharge from hospital (up to 7 days), at first follow-up (3-6months), and at the second follow-up (12 months))
- New Onset of Atrial Fibrillation, as Evaluated Through Follow up ECG at Discharge, First Follow up (3-6months) and at Second Follow up (12 Months)(At discharge from hospital, (up to 7 days), at first follow-up (3-6month), and at the second follow-up (12 months))