A prospective, multi-centre, single-arm, real-world study to evaluate the safety and performance of Myval Inception Transcatheter Heart Valve System in patients with symptomatic severe native aortic stenosis
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- Early Safety (30 days): Composite of freedom from all-cause mortality, stroke, major bleeding (VARC type 2–4), major vascular or structural complications, AKI (Stage 3/4), moderate/severe aortic regurgitation, new pacemaker implantation, and reintervention related to device.
研究概览
简要总结
This is a prospective multicentre singlearm real world post market study designed to evaluate the safety and performance of the Myval Inception Transcatheter Heart Valve THV System in patients with symptomatic severe native aortic stenosis. The study aims to enroll approximately 200 patients across 20 sites in India. The primary objective is to assess early safety at 30 days and clinical efficacy at 1 year based on VARC 3 criteria. Patients will undergo valve implantation via the transfemoral approach and be followed up clinically and telephonically for up to 5 years. The study focuses on generating long term real world evidence for the Myval Inception THV system to support its use in clinical practice.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient more than and equal to 18 years of age.
- •Patient or their legally acceptable representative (LAR) has provided written informed consent as approved by the Institutional Review Board (IRB)Independent Ethics Committee (IEC) of the study site to participate in the study.
- •Patients with symptomatic severe native aortic stenosis who are suitable for the treatment with Myval Inception THV System as judged by a Investigator and or heart team.
排除标准
- •Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study
- •Pregnant and/or lactating female patients
- •Any condition, which, in Investigator’s and/or heart team’s opinion would preclude safe participation of patients in the study.
结局指标
主要结局
Early Safety (30 days): Composite of freedom from all-cause mortality, stroke, major bleeding (VARC type 2–4), major vascular or structural complications, AKI (Stage 3/4), moderate/severe aortic regurgitation, new pacemaker implantation, and reintervention related to device.
时间窗: 30 days and 1 year
Clinical Efficacy (1 year): Composite of freedom from all-cause mortality, stroke, and hospitalization due to valve- or procedure-related causes.
时间窗: 30 days and 1 year
次要结局
- All cause mortality(All stroke)
研究者
Dr Ashok Thakkar
Meril Life Sciences Pvt. Ltd.