NL-OMON48568已完成不适用
Safety and Performance Evaluation of the AccuCinch Ventricular Repair System for the treatment of heart failure, with or without functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - CORCINCH-E
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
研究概览
简要总结
Trial ended prematurely
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. Age >= 18 yrs
- •2. Subjects who present with heart failure with or without functional mitral
- •regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology
- •a. For subjects with FMR severity of FMR: >= Moderate 2+
- •b. For subjects without FMR, LVEDD >= 55 mm
- •3. LVEF >=20% to <=40%. Patients with EF >40% are excluded
- •4. Symptom Status: NYHA II- IV (i.e., ambulatory)
- •5. Patients to be considered for the present study will be required to have
- •received all appropriate guidelines-recommended medical therapies for at least
- •3 months prior to the enrollment with stable doses of drugs for at least 1 month
- •6. Surgical risk:
- •a) Voor patiënten met alleen FMR: Het Hart Team moet de patiënt als hoog risico
- •evalueren en mag de bestaande risico scores gebruiken of comorbiditeiten om
- •blijk te geven van hoge-risicofactoren. Hoog risico voor mitralisklepchirurgie
- •wordt gedefinieerd met behulp van erkende risicoscores (STS, Euro-Score II) in
- •combinatie met comorbiditeiten zoals aanbevolen door het MVARC
- •(fragiliteitsindex; stoornis van belangrijke orgaansystemen die postoperatief
- •niet verbetert; belemmeringen specifiek voor de ingreep) (MVARC deel 1).
- •b) Voor alle patiënten: de patiënt is geschikt voor cardiale chirurgie
- •(namelijk, de patiënt is in een conditie die voldoende is voor een potentiele
- •conversie naar open chirurgie in geval van procedurele complicaties). Dit
- •criterium voegt een veiligheids niveau voor patiënten toe.
- •a. For patients with FMR only: The Heart Team must assess as high-risk and may
- •utilize risk score or comorbidities to demonstrate high risk features. High
- •risk for mitral valve surgery is defined utilizing established risk scores
- •(STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC
- •(frailty index; major
- •4631_E CL Confidential Page 10 of 100
- •organ system compromise not to be improved postoperatively; procedure specific
- •impediments) (MVARC Part 1)
- •b. For all patients: Subject is eligible for cardiac surgery (namely, the
- •patient is in a condition that allows a potential conversion to open surgery in
- •case of procedural complications). This criterion adds a safety level for the
- •7. Completion of all qualifying diagnostic and functional tests and agrees to
- •comply with study follow-up schedule
- •8. Patients required to have an ICD are required to have ICD implant at least 1
- •month prior to enrollment
排除标准
- •1. Life expectancy <1 yr due to noncardiac conditions
- •2. NYHA functional class IV (i.e., non-ambulatory) or ACC/AHA stage D heart
- •3. Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic
- •support or mechanical hemodynamic support
- •4. Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive
- •pericarditis, or any other structural heart disease causing heart failure other
- •than dilated cardiomyopathy of either ischemic or non-ischemic etiology
- •5. Fixed pulmonary artery systolic pressure >70 mm Hg
- •6. Physical evidence of right-sided congestive heart failure with
- •echocardiographic evidence of moderate or severe right ventricular dysfunction
- •7. Mitral valve anatomy which may preclude proper device treatment
- •8. Mitral valve area <4.0 cm2 (if new device therapy may further decrease the
- •mitral orifice area)
- •9. Any prior mitral valve surgery or transcatheter mitral valve procedure
- •10. Stroke or transient ischemic event within 30 days
- •11. Modified Rankin Scale >= 4 disability
- •12. Need for emergent or urgent surgery for any reason or any planned cardiac
- •surgery within the next 12 months
- •13. Untreated clinically significant coronary artery disease requiring
- •revascularization
- •14. Severe symptomatic carotid stenosis (>70% by ultrasound).
- •15. Myocardial infarction <= 30 days
- •16. Any percutaneous cardiovascular intervention, cardiovascular surgery, or
- •carotid surgery within 30 days
- •17. Tricuspid valve disease requiring surgery or severe tricuspid regurgitation
- •(per ASE guidelines)
- •18. Aortic valve disease requiring surgery
- •19. Moderate or severe aortic valve stenosis or regurgitation
- •20. Aortic valve prosthesis
- •21. Fluoroscopic or echocardiographic evidence of severe aortic arch
- •calcification, mobile aortic atheroma, intracardiac mass, thrombus, or
- •22. Need for any cardiovascular surgery (other than for MV disease)
- •23. Active endocarditis
- •24. Anatomical pathology/constraints preventing appropriate access/implant of
- •the AccuCinch System (e.g., femoral arteries will not support a 20F system)
- •25. Known allergy to nickel, polyester, or polyethylene
- •26. Active infections requiring current antibiotic therapy
- •27. Currently participating in another investigational study
- •28. Subjects in whom transesophageal echocardiography is contraindicated or
- •29. Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)
- •30. Subjects in whom anticoagulation or antiplatelet therapy is contraindicated
- •31. Any prior true anaphylactic reaction to contrast agents; defined as known
- •anaphylactoid or other non-anaphylactic allergic reactions to contrast agents
- •that cannot be adequately pre-medicated prior to procedure.
- •32. Implant or revision of any rhythm management device (CRT or CRT-D) or
- •implantable cardioverter defibrillator within 1 month
- •33. Absence of CRT with class I indication criteria for biventricular pacing
- •(left bundle branch block pattern and QRS duration >=150 ms)
- •34. Subjects on high dose steroids or immunosuppressant therapy
- •35. Any condition making it unlikely the patient will be able to complete all
- 另有 4 项未显示
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