Heart FailureNCT02624960
Safety and Performance of the AccuCinch® System
A study testing Accucinch Implant in people with Heart Failure and Mitral Valve Insufficiency, run by Ancora Heart, Inc..
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Mitral Valve Insufficiency
- What is being tested?
- Accucinch Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 31Show fewer
- 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
About this study
Official title: Safety and Performance of the AccuCinch® Ventricular Repair System
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.
- Conditions
- Heart Failure, Mitral Valve Insufficiency
- Being tested
- Accucinch Implant
- Medical subject headings
- Heart Failure, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accucinch ImplantDevice
Percutaneous implantation of the Accucinch Implant in the mitral subannular space
| Study group | Role | What they receive |
|---|---|---|
| Accucinch Implant | Experimental | Accucinch Implant procedure is completed Receives: Device: Accucinch Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 30 Days, 6 months, 12 months, and 2 years
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
Measured: 30 days after the index procedure
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)
Measured: 6 months, 1 year, 2 years post index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2015 (estimated)
- Study startSep 2016
- Primary completionMar 2019 (estimated)
- Study completionSep 2019 (estimated)
Why it stopped: Sponsor withdrew and updated study design. Refer to NCT03183895.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Schofer, MD, PhD, Principal investigator, Medical Director, Medical Care Center Hamburg; Dept Chief, Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624960
- Sponsor's protocol ID
- 4432
- Status last verified
- Jul 2018
- First submitted
- 1 Dec 2015
- Last updated
- 27 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the AccuCinch® Ventricular Repair System
- ClinicalTrials.gov ID
- NCT02624960
- Acronym / sponsor ID
- 4432
- Conditions
- Heart Failure, Mitral Valve Insufficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew and updated study design. Refer to NCT03183895.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 9 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accucinch Implant | Experimental | Device: Accucinch ImplantAccucinch Implant procedure is completed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (31 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accucinch ImplantPercutaneous implantation of the Accucinch Implant in the mitral subannular space | Device | Accucinch Implant |
Primary outcome
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.
3 secondary outcomes
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joachim Schofer, MD, PhD principal investigator
Medical Director, Medical Care Center Hamburg; Dept Chief, Percutaneous Treatment of Structural Heart Disease, Albertinen Heart Center, Hamburg Germany
Questions about this trial
What is this clinical trial studying?
A study testing Accucinch Implant in people with Heart Failure and Mitral Valve Insufficiency, run by Ancora Heart, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2018; AzTrials last refreshed its copy on 6 Nov 2026.