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

Completed

• Conditions: dilation of heart left ventricle; functional mitral regurgitation; Heart failure; 10019280

• Registration Number: NL-OMON48568
• Lead Sponsor: Ancora Heart, Inc.

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-06-25
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

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%. 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
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

1. Life expectancy <1 yr due to noncardiac conditions
2. NYHA functional class IV (i.e., non-ambulatory) or ACC/AHA stage D heart
failure
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
vegetation
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
high risk
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
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

Study & Design

• Study Type: Interventional
• Study Design: Not specified