NL-OMON48880招募中不适用
MANTA* versus suture-based closure after Transcatheter Aortic Valve Implantation Trial - MASH TAVI
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Patients undergoing elective transfemoral TAVI for severe aortic valve stenosis with any commercially-available transcatheter heart valve (THV)
- •- Common femoral artery diameter > 5.0mm (14 - 22F compatible)
排除标准
- •- Symptomatic leg ischaemia
- •- Previous thromboendarterectomy or plastic patch of the common femoral artery
- •- Previous implantation of a suture-based VCD less than 30 days before, or a plug-based VCD within 6 months
- •- Unilateral or bilateral lower extremity amputation
- •- Systemic infection or a local infection at or near the access site
- •- Allergy to the components any of both devices (i.e. bovine materials or any other device material, including collagen and/or collagen products, polyglycolic or polylactic acid, stainless steel or nickel)
- •- Active bleeding or bleeding diathesis including thrombocytopenia (platelet count <50,000 cells/UL), thrombasthenia, hemophilia, or von Willebrand disease
- •- Patients in whom continuous oral anticoagulation therapy cannot be stopped for the peri-procedural period or patients with INR >1.8 at the time of the procedure
- •- Patient unable to be adequately anti-coagulated for the procedure
- •- Morbidly obese or cachectic (BMI >40 kg/m2 or <20 kg/m2)
- •- Anatomical and procedural contraindication for suture-based or Manta closure such as a lack of proper puncture site in the common femoral artery in terms of calcification, size, and atherosclerotic disease
- •- Absence of computed tomographic data of the access site before the procedure
- •- Patient cannot adhere to or complete the investigational protocol for any reason including but not limited to geographical residence, psychiatric condition or life threatening disease
- •- Known pregnancy at time of randomization (in women of childbearing potential a negative pregnancy test is mandatory)
- •- Participating in trials in which the primary endpoint includes bleeding or vascular complications
研究者
相似试验
已完成
不适用
Manta™ Versus Suture-based Closure After Transcatheter Aortic Valve Implantation TrialAortic Valve StenosisNCT03811119Erasmus Medical Center151
招募中
不适用
Staples versus Sutures for Wound Closure after Total Hip Arthroplastycontaminationinfection1004079210005944NL-OMON35908Academisch Medisch Centrum1,800
招募中
不适用
Comprasion of two different methods of peritoneum closure in Laparoscopic Inguinal Hernia surgery (TAPP)CTRI/2022/11/047211Rajagopal C
已完成
不适用
Safety and Efficacy of transcatheter closure of paravalvular leaksJPRN-UMIN000019656Kyushu University Hospital15
Unknown
1 期
The Effect of Closure Technique and Postoperative Socket Irrigation on Postoperative Complications After Impacted Mandibular Third Molar Surgery: A Randomized Controlled TrialPostoperative complications after impacted mandibular third molar surgery in healthy human volunteersSocket irrigationClosure techniquesPostoperative complicationsImpacted mandibular third molarTCTR20230517005Chulalongkorn University48