Mitral RegurgitationCINCH-2NCT00800046
A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
A study testing AccuCinch® Ventriculoplasty System in people with Mitral Regurgitation and Mitral Valve Regurgitation, run by Ancora Heart, Inc. at 8 sites in 3 countries.
Trial summary
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair. Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation, Mitral Valve Regurgitation, Functional Mitral Regurgitation
- What is being tested?
- AccuCinch® Ventriculoplasty System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Nov 2008to Jan 2021
- 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
- Age ≥ 18 years
- Severity of FMR: ≥ Moderate (i.e., 2+)
- 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 (specific EuroSCORE (LES or ESII), STS, or comorbidities should demonstrate high risk features)
- Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
Who cannot join
- 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 (CAD) requiring revasularization
- Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Any planned cardiac surgery within the next 6 months (including right heart procedures)
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- NYHA class (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
- Fixed pulmonary artery systolic pressure >70 mmHg
- Severe tricuspid regurgitation (per ASE guidelines and graded by the Echo Core Lab)
- 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/contraints preventing appropriate access/ implant of the AccuCinch System
- Renal insufficiency (i.e., eGFR of <30ml/min/1.73m2 ; Stage 4 or 5 CKD)
- 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 or antiplatelet therapy is contraindicated
- 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 (CRT or CRTD) or implantable cardioverter defibrillator within 1 month
- Absence of CRT with class I indication criteria for biventricular pacing (left bundle branch block pattern and QRS duration ≥150 ms)
- On high dose steroids or immunosuppressant therapy
- Female subjects who are pregnant or lactating
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany6 sites
University Hospital Freiburg-Bad Krozingen
Bad Krozingen
Immanuel Klinikum Bernau Herzzentrum Brandenburg
Bernau
St.-Johannes-Hospital
Dortmund
Universitätsklinikum Düsseldorf
Düsseldorf
Cardiovascular Center Frankfurt
Frankfurt
Medical Care Center Hamburg University Cardiovascular Center
Hamburg, 22527
About this study
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.
- Being tested
- AccuCinch® Ventriculoplasty System
- Keywords
- Mitral valve, Mitral regurgitation, Functional mitral regurgitation, MR, FMR, Heart valve, Mitral valve insufficiency, Valve repair, Valve disorder, Cardiac surgery
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCinch® Ventriculoplasty SystemDevice
Mitral valve repair due to functional disease
| Study group | Role | What they receive |
|---|---|---|
| AccuCinch® Ventriculoplasty System | Experimental | Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System. Receives: Device: AccuCinch® Ventriculoplasty System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety through 30 days and reduction in MR acutely and at 30 days.
Measured: 30 days
Secondary outcomes (1)
Safety and reduction in MR at 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ancora Heart, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joachim Schofer, Prof. Dr., Principal investigator, Medical Care Center Prof. Mathey, Prof. Schofer, GmbHPatrick Perier, MD, Principal investigator, Cardiovascular Center Bad Neustadt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800046
- Sponsor's protocol ID
- 1436
- Acronym
- CINCH-2
- Status last verified
- Jul 2021
- First submitted
- 26 Nov 2008
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Percutaneous Repair of Functional Mitral Regurgitation Using the Ancora Heart, Inc. AccuCinch® Ventricular Repair System - The CINCH-2 Study
- ClinicalTrials.gov ID
- NCT00800046
- Acronym / sponsor ID
- CINCH-2 / 1436
- Keywords
- Mitral valve, Mitral regurgitation, Functional mitral regurgitation, MR, FMR, Heart valve, Mitral valve insufficiency, Valve repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Ancora Heart, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2008 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 1 Dec 2008 (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.
Prospective single-arm study of the AccuCinch® Ventriculoplasty System in the treatment of mitral valve regurgitation through subvalvular mitral repair.
Purpose: To demonstrate the safety, feasibility and potential efficacy of using the AccuCinch® Ventriculoplasty System to reduce mitral valve regurgitation through subvalvular mitral repair.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCinch® Ventriculoplasty System | Experimental | Device: AccuCinch® Ventriculoplasty SystemPatients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Severity of FMR: ≥ Moderate (i.e., 2+)
- 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 (26 listed)
- 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 (CAD) requiring revasularization
- Hemodynamic instability: Hypotension (systolic pressure <90 mmHg) 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® Ventriculoplasty SystemMitral valve repair due to functional disease | Device | AccuCinch® Ventriculoplasty System |
Primary outcome
Safety through 30 days and reduction in MR acutely and at 30 days.
Time frame: 30 days
1 secondary outcome
Safety and reduction in MR at 1 year.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
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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, Prof. Dr. principal investigator
Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
Patrick Perier, MD principal investigator
Cardiovascular Center Bad Neustadt
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCinch® Ventriculoplasty System in people with Mitral Regurgitation and Mitral Valve Regurgitation, run by Ancora Heart, Inc. at 8 sites in 3 countries.
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 7 inclusion and 26 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: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety through 30 days and reduction in MR acutely and at 30 days. (time frame: 30 days). 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 29 Jul 2021.