Bewertung der Sicherheit und Leistung des ventrikulären Reparatursystems AccuCinch® für die Behandlung von Herzinsuffizienz mit oder ohne funktionelle Mitralklappeninsuffizienz aufgrund einer dilatativen ischämischen oder nicht ischämischen Kardiomyopathie

Device: Left ventricular restoration

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- Age = 18 years

- Subjects who present with heart failure with or without functional mitral
regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology

1. For subjects with FMR, severity of FMR: = Moderate 2+

2. For subjects without FMR, LVEDD = 55 mm

- Ejection Fraction: =20 to =40%

- Symptom Status: NYHA II-IVa

- Patients to be considered for the present study will be required to have received all
appropriate guidelines-recommended therapies for at least 3 months prior to the
enrollment with stable doses of drugs for at least 1 month.

- Surgical risk:

1. 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 organ system compromise not to be improved postoperatively;
procedure specific impediments) (MVARC Part 1)

2. 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

- Completion of all qualifying diagnostic and functional tests and agrees to comply with
study follow-up schedule

- Patients required to have an ICD are required to have ICD implant at least 1 month
prior to enrollment

Exclusion Criteria:

- Life expectancy <1 yr due to noncardiac conditions

- NYHA functional class IVb or ACC/AHA stage D heart failure

- Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or
mechanical hemodynamic support

- Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or
any other structural heart disease causing heart failure other than dilated
cardiomyopathy of either ischemic or nonischemic etiology

- Fixed pulmonary artery systolic pressure >70 mm Hg

- Physical evidence of right-sided congestive heart failure with echocardiographic
evidence of moderate or severe right ventricular dysfunction

- Mitral valve anatomy which may preclude proper device treatment

- Mitral valve area <4.0 cm2 (if new device therapy may further decrease the mitral
orifice area)

- Any prior mitral valve surgery or transcatheter mitral valve procedure

- Stroke or transient ischemic event within 30 days

- Modified Rankin Scale = 4 disability

- Need for emergent or urgent surgery for any reason or any planned cardiac surgery
within the next 12 months

- Untreated clinically significant coronary artery disease requiring revascularization

- Severe symptomatic carotid stenosis (>70% by ultrasound).

- Myocardial infarction = 30 days

- Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid
surgery within 30 days

- Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE
guidelines; core lab assessment)

- Aortic valve disease requiring surgery

- Moderate or severe aortic valve stenosis or regurgitation

- Aortic valve prosthesis

- Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile
aortic atheroma, intracardiac mass, thrombus, or vegetation

- Need for any cardiovascular surgery (other than for MV disease)

- Active endocarditis

- Anatomical pathology/constraints preventing appropriate access/implant of the
AccuCinch System (e.g., femoral arteries will not support an 20F system)

- Known allergy to nickel, polyester, or polyethylene

- Active infections requiring current antibiotic therapy

- Subjects in whom transesophageal echocardiography is contraindicated

- Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2; Stage 4 or 5 CKD)

- Subjects in whom anticoagulation or antiplatelet therapy is contraindicated

- 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.

- Implant or revision of any rhythm management device (CRT or CRT-D) or implantable
cardioverter defibrillator within 1 month

- Absence of CRT with class I indication criteria for biventricular pacing (left bundle
branch block pattern and QRS duration =150 ms)

- Subjects on high dose steroids or immunosuppressant therapy

- 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

- Patient is unable or unwilling to sign written patient information sheet and informed
consent form before study enrollment. This study excludes vulnerable populations as
defined in protocol section 18.