Back to resultsSafety and Performance of the AccuCinch® System
Primary Purpose
Heart Failure, Mitral Valve Insufficiency
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Accucinch Implant
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Accucinch Implant
Arm Description
Accucinch Implant procedure is completed
Outcomes
Primary Outcome Measures
The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject
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
Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met.
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.
Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of 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
Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02624960
Brief Title
Safety and Performance of the AccuCinch® System
Official Title
Safety and Performance of the AccuCinch® Ventricular Repair System
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor withdrew and updated study design. Refer to NCT03183895.
Study Start Date
September 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
September 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ancora Heart, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Mitral Valve Insufficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Accucinch Implant
Arm Type
Experimental
Arm Description
Accucinch Implant procedure is completed
Intervention Type
Device
Intervention Name(s)
Accucinch Implant
Intervention Description
Percutaneous implantation of the Accucinch Implant in the mitral subannular space
Primary Outcome Measure Information:
Title
The additive reduction in the mitral annular axial dimensions (anteroposterior plus commissure-to-commissure axes) measured via echocardiography, paired by subject
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Device Success: Percentage of patients in whom all pre-specified device performance endpoints are met but no pre-specified device complications are met.
Description
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.
Time Frame
30 Days, 6 months, 12 months, and 2 years
Title
Procedural Safety: Incidence rate of the occurrence of the individual pre-specified safety events that occur within 30 days of the index procedure
Description
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
Time Frame
30 days after the index procedure
Title
Long Term Safety: Incidence rate of the occurrence of the individual pre-specified safety events at 6 months, 1 year, and 2 years.
Description
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)
Time Frame
6 months, 1 year, 2 years post index procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joachim Schofer, MD, PhD
Organizational Affiliation
Medical Director, Medical Care Center Hamburg; Dept Chief, Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Safety and Performance of the AccuCinch® System
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