Feasibility of the AccuCinch® System for Left Ventricular... | NCT02153892

Status Module

Label	Type	Description	Intervention Names
Multi-center, prospective, single-arm study	Other	To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.	Device: GDS Accucinch System

Name	Type	Description	Arm Group Labels	Other Names
GDS Accucinch System	Device	Percutaneous Coronary Intervention	Multi-center, prospective, single-arm study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Procedural Success	Successful use and implantation of an Accucinch System without Major Adverse Events (MAE) defined as the occurrence of any of the following: All-cause mortality, Device and/or procedure-related death; Peri-procedural myocardial infarction (MI) < or equal to 72 hrs after index procedure; Major stroke; Urgent or emergent conversion to surgery or repeat procedure (surgical or interventional therapy) for mitral valve or heart failure related deterioration; Left ventricular perforation; Major vascular complications; Major bleeding (including cardiac tamponade)	72 hours post-procedure
Device Success	Successful vascular access, delivery, and retrieval of the delivery system; Ability to establish access to the sub-annular groove, to deploy the Anchors, and the Anchor Links, to apply tension to the Cinch Cable, to reshape the mitral annulus, to deploy the Lock, and to cut the Cinch Cable; Intended performance of the Accucinch System measured by TTE acutely post-cinch with a reduction of MR by at least one grade	24 hours post-procedure
Clinical Safety Measures	Defined as freedom from MAE at discharge or 7 days post-procedure, whichever comes first; Safety measures will be reviewed and adjudicated by an independent clinical events committee (CEC); Echocardiographic measures will be assessed by an independent echocardiography core laboratory	7 day post procedure

Secondary Outcomes

Measure	Description	Time Frame
Clinical Measure	NYHA Class improvement of at lease one score from baseline	30 day post-procedure
Echocardiographic Measures - Composite	Mitral Valve Measures: One grade reduction in MR (e.g. 3+ to 2+), or; Reduction in PISA EROA at least 25% from baseline, or; Reduction in Regurgitant Volume at least 25% Left Ventricular Measures: Reduction in Left Ventricular size (Left Ventricular End Diastolic Dimension - LVEDD) at least 5% from baseline, or: Reduction in Left Ventricular volume (Left Ventricular End Diastolic Volume -LVEDV) at least 5%, or Increase in ejection fraction (LVEF) at least 10% from baseline Left Atrial Measures: Left atrial volume index (biplane area-length method). The above echocardiographic measures will be assessed by an independent core laboratory

Other Outcomes

Measure	Description	Time Frame
Additional Measures - Composite	Safety measures (adjudicated by an independent Clinical Events Committee): Mortality: all-cause, cardiovascular, and non-cardiovascular; Spontaneous Myocardial Infarction (>72 hrs post-index procedure); Major and life-threatening bleeding; Major stroke: disabling and non-disabling; Major vascular complication (access site, non-access site); Acute Kidney Injury (< or equal to 72 hrs post-procedure): based on the modified RIFLE Stage 3 (including renal replacement therapy), Stage 2, and Stage 1; Failure of current therapy for functional mitral regurgitation requiring re-hospitalization or prolonged hospitalization for FMR-related symptoms and worsening heart failure with NYHA class III or IV, or requiring conversion to surgery; Anchor(s) migration or Anchor(s) dislocation (as assessed by fluoroscopic images or CT) (when applicable)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age > 18 years
Subjects with severe symptomatic functional mitral regurgitation of ≥ 3+ secondary to left ventricular (LV) remodeling and/or annular remodeling, as measured in accordance with the current ASE guidelines and suitable for treatment in accordance with the current AHA/ACC guidelines:
- Left ventricular ejection fraction (LVEF) ≥ 20% and ≤ 40%
- Stable cardiac medical regimen for heart failure for at least 1 month
- Stable NYHA Classification (Class III and above) for at least 1 month
The subject has been informed of the nature of the study, agrees to its provisions, including the possibility of conversion to surgery, and has provided written informed consent.

Exclusion Criteria:

Candidates will be excluded from the study if any of the following conditions are present:

Myocardial infarction within 90 days of the intended treatment with the device
Prior surgical, transcatheter, or percutaneous mitral valve intervention or mitral valve prosthesis
Subject has untreated coronary artery disease, which in the opinion of the treating physician and/or heart team, is clinically significant and requires revascularization
Non-ambulatory NYHA Class IV symptoms of heart failure or subjects in cardiogenic shock or with hemodynamic instability requiring IV inotropic support or mechanical support devices
Subject has the need for emergent surgery for any reason
Subjects in whom sufficient quality of echocardiography (TTE and TEE) cannot be obtained
Echocardiography evidence of primary mitral valve disease causing MR or MS;
Moderate to severe pulmonary hypertension (PA systolic pressure ≥ 80 mm Hg) as assessed by echocardiography
Evidence of mitral valve stenosis with an estimated valve area less than 3.5 cm2
Mitral valve pathology that would prevent adequate function of the GDS Accucinch System
Subject is on dialysis or estimated GFR < 30mL/min/1.73m2 (Cockcroft-Gault Formula)d d Israni AK, et al. Laboratory Assessment of Kidney Disease, in Brenner and Rector's The Kidney, 9th ed. chapter 25
Greater than mild mitral annular calcification observed by fluoroscopy
Presence of aortic valve prosthesis
Moderate to severe aortic valve stenosis or calcification observed by echocardiography or fluoroscopy
Severe aortic arch calcification or mobile aortic atheroma observed by echocardiography or fluoroscopy
Active bacterial endocarditis or active sepsis
History of bleeding diathesis or coagulopathy
History of stroke within the prior 6 months
Subjects in whom anticoagulation is contraindicated
Any clinical evidence that the investigator feels would place the subject at increased risk with the placement of the device
Concurrent medical condition with a life expectancy of less than 12 months
Currently participating in another investigational drug or device study that has not reached its primary endpoint
Co-morbid conditions that place the subject at an unacceptable surgical risk (e.g. severe chronic obstructive pulmonary disease, hepatic failure, immunological abnormalities, and hematological abnormalities)
Subject with indication for concomitant surgery such as coronary artery bypass graft (CABG), aortic valve reconstruction or replacement, left ventricular remodeling surgery and congenital repair
Any cardiac resynchronization therapy within the last 9 months prior to treatment
Subject on high dose steroids or immunosuppressant therapy
Current problems with substance abuse (e.g. alcohol, illegal drugs, etc.)
Female subjects who are pregnant, lactating, or planning pregnancy within next the 36 months. Note: Childbearing age should be instructed to use safe contraception during their participation in this study.
Subjects who are unable or unwilling to comply with the follow-up schedule and requirements
Subject has known hypersensitivity to contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to study required medications, to nickel, or to polyurethanes
Femoral artery lumen diameter of < 5.5 mm, or severe ilio-femoral tortuosity or calcification that would prevent safe placement of the 16Fr introducer sheath

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases