NL-OMON49230撤回4 期
Transcatheter Repair of Mitral Regurgitation with Cardioband System Post Market Study (MiBAND): A European prospective, multicenter study to assess transcatheter mitral valve repair with Edwards Cardioband System in patients with symptomatic mitral regurgitation. - MiBAND Study
Edwards Lifesciences, LCC0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5
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 至 99（—）
入选标准
- •1. Age * 18 years
- •2. MR (* 2+ by echocardiography * refer to Appendix C)
- •3. NYHA Class II-III-ambulatory IV heart failure symptoms despite guideline
- •directed medical therapy (GDMT), including Cardiac Resynchronization Therapy
- •(CRT) if indicated
- •4. LVEF >20% and LVEDD * 80mm by echocardiography;
- •5. Patient is eligible to receive the Edwards Cardioband Mitral System per the
- •current approved indications for use.
- •6. Patient is willing and able to attend all follow-up visits and perform all
排除标准
- •1. Active bacterial endocarditis
- •2. Severe organic lesions with retracted chordae or congenital malformations
- •with lack of valvular tissue
- •3. Heavily calcified annulus or leaflets
- •4. Patients in whom transesophageal echocardiography is contraindicated
- •5. Untreatable hypersensitivity or contraindication to any of the following:
- •Anticoagulation/antiplatelet regimen
- •Nitinol alloys (Nickel and Titanium)
- •Contrast media
- •6. Any carotid intervention or carotid surgery within 30 days
- •7. Any cardiac surgery or major endovascular surgery within 3 months
- •8. Pre-existing prosthetic heart valve or annuloplasty in the mitral position
- •9. Severe right ventricular (RV) dysfunction (e.g. Pulmonary hypertension
- •[PHTN] * 70 mmHg at rest)
- •10. Renal insufficiency requiring dialysis or severe kidney renal disease with
- •eGFR * 30 mL/min/1.73 m2
- •11. Severe COPD, defined as has recurrent (> 2 per 12 months) hospitalizations
- •for COPD exacerbation, or continuous use of home oxygen
- •12. End-stage Heart Failure with inotrope support and/or consideration for LVAD
- •or heart transplant
- •13. Concurrent medical condition with a life expectancy of less than 12 months
- •in the judgment of the Investigator
- •14. Patient is pregnant or lactating
- •15. Any patient considered to be part of a vulnerable population (as defined in
- •section 12.1)
研究者
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