NCT06634121招募中不适用
Efficacy of Mitraclip Vs. PASCAL for the Treatment of Mitral Regurgitation in an All-comer Population
LMU Klinikum2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2024年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Postprocedural residual MR measured by 3D EROA
研究概览
简要总结
To investigate potential differences in procedural outcomes of both commercially available transcatheter edge-to-edge mitral valve repair devices in a non-selected clinical setting.
详细描述
In the context of M-TEER, two different systems (MitraClip vs. PASCAL) are CE certified and clinically available. In the case of non-complex anatomy, both systems are comparable in terms of effectiveness. Whether this holds true in cases of complex or highly complex anatomy in an "Allcomer patient population" is currently unclear.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age equal or above 18 years
- •Written consent
- •Heart Team recommends M-TEER
排除标准
- •Mitral Stenosis (MV mean PG > 5 mmHg)
- •Cardiogenic shock or hemodynamic instability at the time of intervention
- •Active endocarditis
- •Participant in another interventional cardiology study
结局指标
主要结局
Postprocedural residual MR measured by 3D EROA
时间窗: During the index procedure
residual MR measured by 3D EROA as continuous parameter
次要结局
- Reduction in MR EROA(During the index procedure)
- Comparing EROA in complex vs. non-complex patients(During the index procedure)
- Postprocedural MV opening area(During the index procedure)
- Postprocedural MV inflow gradient(During the index procedure)
- SLDA(During the index procedure, at 30-day follow-up and at 1-year follow-up)
- Conversion to surgery or re-imaging of the MV(During the index procedure, at 30-day follow-up and at 1-year follow-up)
- Stratification by MR etiology(During the index procedure, at 30-day follow-up and at 1-year follow-up)
- Combined endpoint of mortality, repeat MV intervention or HHF(During the index procedure, at 30-day follow-up and at 1-year follow-up)
- Quality of Life(At 30-day follow-up and at 1-year follow-up)
- Exertional dyspnea(At 30-day follow-up and at 1-year follow-up)
研究者
Prof. Dr. med. Jörg Hausleiter
Deputy chief
LMU Klinikum
研究点 (2)
Loading locations...
相似试验
已完成
不适用
PASCAL vs. MitralClip for Mitral Valve Transchatheter Edge-to-Edge RepairFunctional Mitral RegurgitationDegenerative Mitral Valve RegurgitationMitral RegurgitationNCT05865938Heinrich-Heine University, Duesseldorf214
终止
不适用
Transcatheter Mitral Valve Repair for the Treatment of Mitral Valve Regurgitation In Heart Failure (The EVOLVE-MR Trial)Ventricular Remodeling, LeftNCT03891823Montreal Heart Institute9
进行中（未招募）
不适用
MitraClip REPAIR MR StudyMitral Valve RegurgitationNCT04198870Abbott Medical Devices500
Unknown
2 期
Paclitaxel Plus Raltitrexed Plug Compare With Taxol Second-line Treatment for Advanced Gastric CancerAdvanced Gastric CancerNCT02072317Fudan University140
已完成
不适用
Peripherally Inserted Central Catheter (PICC) Thrombosis: Reverse Taper Versus Non-tapered CathetersVenous ThrombosisNCT00728819University of Pennsylvania339