Cardioband Adjustable Annuloplasty System For Transcatheter Repair of Mitral Valve Regurgitation - Cardioband For Transcatheter MV Repair

Valtech Cardio LTD0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•* Age > 18 years
•* Moderate to severe functional MR
•* Symptomatic Patients (NYHA ClassII-IV) despite optimal medical therapy , including CRT if indicated.
•* LVEF * 25%, LVEDD * 70mm
•* Subject is high risk to undergo MV surgery (as assessed by a cardiac surgeon and a cardiologist at the site, and according to ESC/EACTS guidelines on the management of valvular heart disease)
•* Transseptal catheterization and femoral vein access is determined to be feasible
•* Subject is able and willing to give informed consent and follow protocol procedures

•* Active bacterial endocarditis
•* Severe organic lesions with retracted chordae or congenital malformations with lack of valvular tissue
•* Heavily calcified annulus or leaflets
•* Subjects in whom transesophageal echocardiography is contraindicated
•* Untreated clinically significant CAD requiring revascularization
•* Any percutaneous coronary, carotid, endovascular intervention or carotid surgery within 30 days or any coronary or endovascular surgery within 3 months
•* CVA or TIA within 6 months or severe carotid stenosis (>70% by Ultra sound)
•* Renal insufficiency requiring dialysis
•* Life expectancy of less than twelve months
•* Patient is pregnant (urine HCG test result positive) or lactating
•* Known sensitivity or allergy to Nickel or Chromium
•* Known sensitivity or contraindication to procedural medications which cannot be adequately managed medically
•* Bleeding or clotting disorders
•* Subject is participating in concomitant research studies of investigational products
•* Pulmonary hypertension >70mmHg at rest
•* Mitral valve anatomy which may preclude proper device treatment
•* Right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction and severe tricuspid regurgitation

发起方

Valtech Cardio LTD