dilation of heart left ventricle functional mitral regurgitation Heart failure
Conditions
Interventions
Eligible subjects will receive treatment for their condition with the AccuCinch
implant. The device will be implanted using the same technique as similar
devices.
For a detailed description of the p
Sponsors
Ancora Heart, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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% 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 patients. 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
Exclusion criteria
Exclusion criteria: 1. Life expectancy 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 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 =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 protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits 36. Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollme
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The performance and safety endpoints of the AccuCinch System will be assessed by monitoring the patient clinical status (recording of adverse events), assessing quality-of-life scores, and evaluating vital, cardiopulmonary, hematology, biochemistry and functional parameters, cardiopulmonary tests data during the visits within the follow-up period, Also, see above in "Objectives of the study". • Each of the individual primary safety endpoints will be evaluated. The analysis will be performed on the ITT patient population. There is a possibility that there will be sample bias in the patient selection process, due to the available commercial product (Mitraclip). Therefore, investigators are likely to choose patients who are older and more compromised to participate in this clinical study. Therefore, the characteristics of the population will be compared with previously reported, published series | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success and device success will be assessed in the IPP population; reduction of MR and absence of technical of structural or functional failure will be based on Imaging Core Laboratories evaluations of intraprocedural TEE and postprocedural TTE or cardiac CT angiography when available. The proportion of patients with technical and device success will be presented with 95% confidence intervals. Also, see above in "Objectives of the study". | — |
Countries
Netherlands
Outcome results
None listed