Clinical trial NCT02153892: Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
Official title: Clinical Protocol - A Feasibility Study Using the AccuCinch® System in the Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Functional Mitral Regurgitation and Heart Failure
Keywords: Functional Mitral Regurgitation
Heart Failure
Ventricular Reshaping
Lead sponsor: Ancora Heart, Inc.
Sponsor class: INDUSTRY
First posted: 2014-06-03
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.


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

Primary outcomes:
measure: Procedural Success
timeFrame: 72 hours post-procedure
measure: Device Success
timeFrame: 24 hours post-procedure
measure: Clinical Safety Measures
timeFrame: 7 day post procedure
Secondary outcomes:
measure: Clinical Measure
timeFrame: 30 day post-procedure
measure: Echocardiographic Measures - Composite
timeFrame: 30 days post-procedure
measure: Clinical Measure
timeFrame: 30 day post-procedure
measure: Clinical Measure
timeFrame: 30 day post-procedure
Other outcomes:
measure: Additional Measures - Composite
timeFrame: Collected at baseline, peri- and post-procedure, discharge or 7-days (whichever comes first) 30-day, 3, 6, and 12 months and at 2 and 3 years post procedure
Locations:
city: Melbourne
country: Australia
facility: Monash Health
state: Victoria
Study officials:
affiliation: Ancora Heart, Inc.
name: Michael Zapien
role: STUDY_DIRECTOR
References: