Prospective, Multi-centre Clinical Investigation Evaluating the Outcomes of Patients Treated by Redo Transcatheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Transcatheter Aortic Valve
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 550
- 试验地点
- 109
- 主要终点
- Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT)
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.
When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.
The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.
The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).
The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
详细描述
To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)
To determine the factors which predict the acute and long-term outcomes of Redo TAVI
To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team
To determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs
To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
排除标准
- •Bio-prosthetic Valve Failure due solely to paravalvular aortic regurgitation
- •Active endocarditis
- •Untreated acute valve thrombosis
- •Life-expectancy less than 1 year
- •Subject is less than legal age of consent, legally incompetent, or otherwise vulnerable
- •Pregnant or nursing
研究组 & 干预措施
Redo TAVI
Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve
干预措施: Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication (Device)
Explant
Surgical explantation with aortic valve replacement
干预措施: Surgical explantation and aortic valve replacement (Procedure)
Optimal Medical Therapy
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
干预措施: Conservative management (Other)
结局指标
主要结局
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT)
时间窗: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT)
时间窗: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
REVALVE success (Redo TAVI)
时间窗: 30 days
Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25. aortic regurgitation \< moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI)
时间窗: 12 months
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT)
时间窗: 30 days
Composite outcome of freedom from: death/stroke/VARC 3-4 bleeding/major vascular, access-related, or cardiac structural complication/AKI 3 or 4/moderate or severe AR/new permanent pacemaker/device-related surgery or intervention
次要结局
- Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)(End of procedure)
- Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)(30 days)
- Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)(30 days)
- Peak and mean invasive gradient post-procedure (Redo TAVI)(End of procedure)
- In-hospital Clinical Outcomes(Immediately after the procedure/surgery)
- Clinical Outcomes(1, 3 and 5 years)
- Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)(End of procedure)
- Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)(30 days)
- Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)(30 days)
- In-hospital Clinical Outcomes(Immediately after the procedure/surgery)
- Echocardiographic Assessment: Mean gradient(Pre-discharge or at 30 days, 1, 3, 5 years)
- Peak and mean invasive gradient post-procedure (Redo TAVI)(End of procedure)
- Echocardiographic Assessment: Peak velocity(Pre-discharge or at 30 days, 1, 3, 5 years)
- Echocardiographic Assessment: Aortic valve area(Pre-discharge or at 30 days, 1, 3, 5 years)
- Echocardiographic Assessment: Patient-prosthesis mismatch(Pre-discharge or at 30 days)
- Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total(Pre-discharge or at 30 days, 1, 3, 5 years)
- Echocardiographic Assessment: Left ventricular systolic function(Pre-discharge or at 30 days, 1, 3, 5 years)
- Clinical Outcomes(1, 3 and 5 years)