DRKS00013632进行中（未招募）不适用
Treatment of TRIcuspid Regurgitation with the MitraClip Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Signed and dated EC approved study consent form prior to study related procedures
- •Eighteen years of age or older
- •Clinically significant, symptomatic (NYHA Functional Class II or greater), combined mitral and tricuspid regurgitation (per applicable guidelines) requiring interventional valve repair of both (mitral and tricuspid) valves as assessed by the Heart Team.
- •Based on surgical recommendations, the interventional combined mitral and tricuspid repair should be considered in patients:
- •o With at least moderate-to-severe mitral regurgitation AND
- •o with severe secondary TR OR
- •o with at least moderate secondary TR with dilated annulus (=40 mm or >21 mm/m²)
- •NYHA Functional Class II or greater or signs of persistent right heart failure despite optimal medical therapy
- •Determined by the 'HEART Team' (a minimum of one Cardiologist, and one Cardiac Surgeon) to be at high surgical risk for surgical valve repair or replacement and the benefit-risk analysis supports utilization of the MitraClip system
- •Willing to attend study follow-up assessments for up to 1 year
排除标准
- •Moderate or greater mitral or tricuspid valve stenosis
- •o valve area < 3 cm2
- •o Inflow gradient = 5 mmHg
- •A right ventricular lead positioned through the tricuspid valve, which impeds valvular function
- •Carzinoid heart disease with valvular involvement
- •Untreated clinically significant coronary artery disease requiring immediate revascularization
- •Any therapeutic invasive cardiac procedure performed within 30 days of the scheduled implant procedure
- •Myocardial infarction within 30 days of scheduled implant procedure
- •Hemodynamic instability within 30 days of scheduled implant procedure
- •Patient requiring surgery under general anesthesia for any reason within 30 days of scheduled implant procedure
- •Patients with pulmonary artery systolic pressure 2/3 of systemic pressure via transthoracic echocardiography or alternative standard modality (e.g., direct pressure measurement) within 45 days
- •Concomitant clinically significant valve (aortic or pulmonic) disease requiring immediate (± 30 days of study procedure) repair or replacement
- •Active endocarditis or infection within 3 months of scheduled implant procedure
- •Cerebrovascular accident within 3 months of scheduled implant procedure
- •Non-cardiac disease limiting life expectancy to be less than 12 months at baseline evaluation
- •Documented history of bleeding diathesis, coagulopathy or gastrointestinal bleeding within 3 months of scheduled implant procedure
- •Evidence of right sided intracardiac mass, thrombus, or vegetation
- •Previously treated tricuspid valve which included implantation of a bioprosthetic valve or mechanical valve
- •Allergy to cobalt, chromium, nitinol or titanium
- •Known hypersensitivity to anticoagulation therapy or contrast agent, which cannot be adequately medicated
- •Patient is a current intravenous drug user
- •Female of child-bearing potential is pregnant or lactating
- •Patient is currently participating or has participated in another investigational drug or device study within 30 days of study screening activity
研究者
相似试验
招募中
不适用
Annuloplasty for Not-Severe TR in Patients Undergoing MV Repair Versus Mitral Repair Only (NOSTRUM)Tricuspid DiseaseMitral RegurgitationNCT02996552Ospedale San Raffaele142
进行中（未招募）
1 期
Trichuris suis Ova Therapy for Relapsing Multiple Sclerosis - a safety study - TRIMS ARelapsing Multipel SclerosisMedDRA version: 12.0Level: LLTClassification code 10028245Term: Multiple sclerosisMedDRA version: 12.0Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosisMedDRA version: 12.0Level: LLTClassification code 10053395Term: Progressive multiple sclerosisEUCTR2008-007549-29-DKDanish Multiple Sclerosis Research Center10
已完成
不适用
TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter SystemTricuspid Valve InsufficiencyTricuspid RegurgitationTricuspid Valve RegurgitationCardiovascular DiseasesHeart Valve DiseasesHeart DiseasesCardiac Valve AnnuloplastyNCT02981953Edwards Lifesciences40
招募中
不适用
A clinical trial to study the effects of three drugs, 3mixtain, Biodentine and MTA in patients with coronal pulpal infection.CTRI/2018/02/012100DrMutala Jhansi
已完成
1 期
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System™Tricuspid RegurgitationNCT020982004Tech Cardio Ltd.24