Safety and Performance of the AccuCinch® System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02624960
Recruitment Status : Withdrawn (Sponsor re-evaluating study design prior to obtaining regulatory approval)
First Posted : December 9, 2015
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):
Ancora Heart, Inc.

Brief Summary:
This is a single-arm, multi-center, open-label controlled study that will assess the safety and performance of the Accucinch System to induce left ventricular reverse remodeling and reduce the severity of functional mitral regurgitation in symptomatic adult patients with mitral regurgitation and left ventricular remodeling due to dilated cardiomyopathy (ischemic or non-ischemic etiology), who are of high operative risk.

Condition or disease Intervention/treatment Phase
Heart Failure Mitral Valve Insufficiency Device: Accucinch Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance of the AccuCinch® Ventriculoplasty System
Study Start Date : September 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Experimental: Accucinch Implant
Accucinch Implant procedure is completed
Device: Accucinch Implant
Percutaneous implantation of the Accucinch Implant in the mitral subannular space

Primary Outcome Measures :
  1. The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject [ Time Frame: 6 months ]
    The differences between baseline and 6 months in the sum of the two annulus measures will be calculated for each subject and the mean change tested via the paired t-test.

Secondary Outcome Measures :
  1. Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met. [ Time Frame: 30 Days, 6 months, 12 months, and 2 years ]
    Pre-specified endpoints are the following:stroke-free survival AND intended positioning of the original implant AND No additional surgical or interventional procedures AND intended performance of the device (no migration, embolization, fracture, thrombosis, etc AND reduction of MR by at least one grade and reduction of combined mitral annular diameters by at least 20%) AND no device-related complications (erosion, migration, etc.) at 30-days and all subsequent follow-up time points.

  2. Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of the index procedure [ Time Frame: 30 days after the index procedure ]

    Pre-specified safety events include the following:

    • Death
    • Stroke
    • Life-threatening or Extensive bleeding (MVARC scale)
    • Major vascular complications
    • Major cardiac access (e.g., structural) complications
    • Stage 2 or 3 acute kidney injury (AKI)
    • New myocardial infarction or coronary insufficiency requiring PCI or CABG
    • Severe hypotension, heart failure, or respiratory failure
    • Any implant-related dysfunction or other complication requiring surgery or unplanned intervention or prolonged intubation > 24 hours

  3. Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years. [ Time Frame: 6 months, 1 year, 2 years post index procedure ]

    Pre-specified endpoints include the following:

    • Death, cardiac, non-cardiac
    • Stroke
    • Mitral valve reintervention or surgery
    • MI
    • Any device related complication/ dysfunction
    • New atrial fibrillation (AF)
    • New conduction disturbance requiring permanent pacemaker (PM)

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Study patient is an adult of legal consent age
  • Severity of FMR: ≥ Moderate
  • Ejection Fraction: ≥20 to ≤60%
  • Symptom Status: NYHA II-IVa
  • Treatment and compliance with optimal guideline directed medical therapy for heart failure for at least 1 month
  • Surgical risk: Subject is eligible for cardiac surgery

Exclusion Criteria:

  • Patients with significant organic mitral valve pathology (e.g. myxomatous degeneration, mitral valve prolapse or flail leaflets)
  • Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  • Prior surgical, transcatheter, or percutaneous mitral valve intervention
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Hemodynamic instability: Hypotension or requirement for inotropic support or mechanical hemodynamic support
  • Any planned cardiac surgery or interventions within the next 6 months
  • NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
  • Fixed pulmonary artery systolic pressure >70 mmHg
  • Severe tricuspid regurgitation
  • Modified Rankin Scale ≥ 4 disability
  • 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
  • Mitral valve area less than 4.0 cm2
  • Anatomical pathology/constraints preventing appropriate access/implant of the GDS Accucinch System
  • Renal insufficiency
  • Mitral annular calcification
  • Moderate or severe aortic valve stenosis or regurgitation or aortic valve prosthesis
  • Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus or vegetation
  • Active bacterial endocarditis
  • History of stroke within the prior 3 months
  • Subjects in whom anticoagulation is contraindicated
  • Anemia
  • Thrombocytopenia or thrombocytosis
  • Bleeding disorders or hypercoaguable state
  • Active peptic ulcer or active gastrointestinal bleeding
  • Known allergy to nitinol, polyester, or polyethylene
  • 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 the index procedure.
  • Life expectancy < 1 year due to non-cardiac conditions
  • Currently participating in another interventional investigational study
  • Implant or revision of any rhythm management device or implantable cardioverter defibrillator within the prior month
  • Absence of CRT with class I indication criteria for biventricular pacing - Subjects on high dose steroids or immunosuppressant therapy
  • Female subjects who are pregnant, of child bearing potential or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02624960

Sponsors and Collaborators
Ancora Heart, Inc.
Principal Investigator: Joachim Schofer, MD, PhD Medical Director, Medical Care Center Hamburg; Dept Chief, Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg Germany

Responsible Party: Ancora Heart, Inc. Identifier: NCT02624960     History of Changes
Other Study ID Numbers: 4432
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases