NL-OMON55204撤回不适用
A First-in-Human Study to Assess Safety and Performance of the Cardiac Implants Percutaneous Ring Annuloplasty System in the Treatment of Patients with Functional Tricuspid Regurgitation - Percutaneous Ring Annuloplasty System FIH Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 10
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
- •1. Moderate to Severe functional tricuspid regurgitation (FTR) as defined by
- •2. Symptoms of right ventricular (RV) failure despite guideline directed
- •medical therapy, NYHA Class II-IV.
- •3. Multidisciplinary heart team (minimum of three physicians, including Imaging
- •and heart Failure cardiologists and cardiac surgery representatives) agree that
- •percutaneous tricuspid annuloplasty is a reasonable treatment option and
- •consider the subject to be a high risk for surgical annuloplasty.
- •4. >=18 years old at time of enrollment.
- •5. LVEF >= 30% within 45 days prior to index implant procedure.
- •6. PASP < 70 mmHg within 90 days prior to index implant procedure.
- •7. Right Ventricle TAPSE >= 13 mm within 45 days prior to index implant
- •8. Tricuspid valve annular diameter >= 40 mm as measured by baseline TTE in the
- •4 chamber view within 45 days prior to index implant procedure.
- •9. Subject has provided written informed consent.
- •10. Subject agrees to comply with all required post-procedure follow-up visits,
- •including device adjustment.
排除标准
- •1. Acutely decompensated heart failure (i.e. hemodynamically unstable or on IV
- •inotropes).
- •2. Severe RV dysfunction per ASE guidelines3.
- •3. Primary tricuspid pathology (e.g. rheumatic, congenital, infective, etc.).
- •4. Previous tricuspid valve repair or replacement.
- •5. Transvalvular pacemaker or defibrillator lead is present.
- •6. Severe left-sided valve disease.
- •7. Right-sided intra-cardiac mass, thrombus or vegetation is present.
- •8. Inability to properly guide the index implant procedure using TEE (e.g.
- •acoustic window not adequate).
- •9. MI or known unstable angina within the 30-days prior to the implant index
- •10. CVA within 3 months prior to index implant procedure.
- •11. Bleeding disorders, active peptic ulcer or GI bleed.
- •12. Contraindication to anticoagulation or antiplatelet medication, based on
- •investigator*s opinion.
- •13. Chronic oral steroid or immunomodulator use (>= 6 months) or other condition
- •that could impair healing response (e.g. cardiac sarcoidosis or other chronic
- •inflammatory disease).
- •14. Any condition that, in the opinion of the investigator, may render the
- •subject unable to complete the study (life expectancy < 1 year), or lead to
- •difficulties for subject compliance with study requirements.
- •15. Subject is enrolled in another investigational study which has not
- •completed the required primary endpoint follow-up period (Note: patients
- •involved in a long-term surveillance phase of another study are eligible for
- •this study).
- •16. Female patients who are pregnant or lactating.
研究者
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