NL-OMON43420已完成不适用
Percutaneous Treatment of Tricuspid Valve Regurgitation With the TriCinch System* - *PREVENT* Study
4Tech Cardio Ltd.0 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
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Functional symptomatic tricuspid regurgitation (TR) 2+ to 4+ on a scale of 4+ (moderate to severe,
- •according to semi-quantitative echocardiographic color flow doppler evaluation)25 with symptoms such
- •as fluid retention and severe oedema requiring use of diuretics, liver stasis, and severe dilatation of the
- •tricuspid annulus (ie, annular diameter greater than 40 mm) confirmed by echocardiography
- •2. By subject signed and dated approved subject informed consent form prior to any study related procedure
- •3. Available and able to return to the study site for post-procedural follow-up examination.
- •4. Eighteen (18) years of age or older.
排除标准
- •1. Requirement for concomitant cardiac procedure (other than atrial fibrillation correction surgery,
- •closure of PFO (Patent Foramen Ovale) or ASD (Atrial Septal Defect), or PTCA (percutaneous
- •treatment of coronary artery) or CAD (coronary artery bypass surgery) from 1 to 3 months after or
- •before other procedure.
- •2. Presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease
- •that will limit the subject*s life expectancy to less than one year.
- •3. Cerebro-vascular event within the past 6 months.
- •4. History of mitral/tricuspid endocarditis within the last 12 months.
- •5. Organic tricuspid disease
- •6. Contraindication or known allergy to device*s components, aspirin, anti-coagulation therapy or
- •contrast media that cannot be adequately premedicated.
- •7. Severe hypertension (SBP >= 180 mmHg and/or DBP >= 110 mmHg, measurement done by
- •sphygmomanometer with stethoscope, allow the patient to sit for at least 5 minutes before beginning
- •BP measurements)26.
- •8. Female patient is pregnant (urine HCG test result positive) or lactating.
- •9. Known alcohol or drug abuser.
- •10. Currently participating in the study of an investigational drug or device.
- •11. At heart team's judgement, patient IVC dimension is not adequate for device implantation.
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