Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluate the Safety and Performance of the AccuCinch® Ventricular Repair System - The CorCinch-EU Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03183895
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

Brief Summary:
This is an international multi-center, non-randomized, prospective safety and performance study to evaluate the AccuCinch® Ventricular Repair System for the treatment of heart failure, with or without functional mitral regurgitation due to dilated ischemic or non-ischemic cardiomyopathy

Condition or disease Intervention/treatment Phase
Heart Failure Mitral Valve Insufficiency Cardiomyopathies Device: Mitral valve repair Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Performance Evaluation of the AccuCinch® Ventricular Repair System for Functional Mitral Regurgitation Due to Dilated Ischemic or Non-Ischemic Cardiomyopathy - The CorCinch-EU Study
Actual Study Start Date : January 15, 2019
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy

Arm Intervention/treatment
Experimental: AccuCinch® Ventricular Repair System Device: Mitral valve repair
The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.




Primary Outcome Measures :
  1. Safety outcome: 30-day major adverse events (MAEs) [ Time Frame: 30-day ]

    Major adverse event (MAE) where MAE is a composite of the following device- or procedure-related events:

    A. All-cause mortality

    B. Stroke

    C. Life-threatening bleeding (MVARC scale)

    D. Major vascular complications

    E. Major cardiac structural complications

    F. Myocardial infarction or coronary ischemia requiring PCI or CABG

    G. Stage 2 or 3 acute kidney injury (includes new dialysis)

    H. Severe hypotension, worsening of heart failure, or respiratory failure requiring intravenous pressors or invasive or mechanical heart failure treatments such as ultrafiltration or hemodynamic assist devices, including intra-aortic balloon pumps or left ventricular or biventricular assist devices, or prolonged intubation for >48 h.

    I. Emergency surgery or re-intervention related to the device or access procedure



Secondary Outcome Measures :
  1. Technical success: Successful access, delivery, and retrieval of AccuCinch System components, successful deployment of the AccuCinch implant without need for unplanned or emergency surgery or re-intervention [ Time Frame: 30-day ]
    Successful access, delivery, and retrieval of all AccuCinch catheters. Deployment and correct positioning of the intended AccuCinch implant, and no need for additional unplanned or emergency surgery or re-intervention related to the device or access procedure measured upon completion of the procedure.

  2. Structural performance: Assessment of device integrity [ Time Frame: 30-day ]
    No migration, embolization, detachment, fracture, hemolysis, thrombosis or endocarditis; and no para-device complications (erosion, effusion requiring surgery or drainage or producing tamponade, damage to the MV apparatus)

  3. Clinical outcome: Freedom from re-hospitalizations or re-interventions for the underlying condition [ Time Frame: 30-day ]
    Freedom from re-hospitalizations or re-interventions for the underlying condition

  4. Clinical outcome: Improvement in NYHA functional class [ Time Frame: 30-day ]
    Improvement in NYHA functional class when compared to baseline assessment

  5. Clinical outcome: Improvement in six-minute walk test [ Time Frame: 30-day ]
    Improvement in six-minute walk test (6MWT) when compared to baseline assessment

  6. Clinical outcome: Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) [ Time Frame: 30-day ]
    Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) Quality of Life (QoL) when compared to baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Age ≥ 18 years
  • Subjects who present with heart failure with or without functional mitral regurgitation due to dilated cardiomyopathy of ischemic or non-ischemic etiology

    1. For subjects with FMR, severity of FMR: ≥ Moderate 2+
    2. For subjects without FMR, LVEDD ≥ 55 mm
  • 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 30 days
  • Surgical risk: Subject is eligible for cardiac surgery (specific risk score or comorbidities should demonstrate high risk features, as determined by the Heart Team) High risk for mitral valve surgery is defined utilizing established risk scores (STS, Euro-Score II) in conjunction with comorbidities as recommended by MVARC (frailty index; major organ system compromise not to be improved postoperatively; procedure specific impediments) (MVARC Part 1)
  • Completion of all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule
  • Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment

Exclusion Criteria:

  • Life expectancy <1 yr due to noncardiac conditions
  • NYHA functional class IVb or ACC/AHA stage D heart failure
  • Hypotension (systolic pressure <90 mm Hg) or requirement for inotropic support or mechanical hemodynamic support
  • Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or nonischemic etiology
  • Fixed pulmonary artery systolic pressure >70 mm Hg
  • Physical evidence of right-sided congestive heart failure with echocardiographic evidence of moderate or severe right ventricular dysfunction
  • Mitral valve anatomy which may preclude proper device treatment
  • Mitral valve area <4.0 cm2 (if new device therapy may further decrease the mitral orifice area)
  • Any prior mitral valve surgery or transcatheter mitral valve procedure
  • Stroke or transient ischemic event within 30 days
  • Modified Rankin Scale ≥ 4 disability
  • Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Severe symptomatic carotid stenosis (>70% by ultrasound).
  • Myocardial infarction ≤ 30 days
  • Any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 30 days
  • Tricuspid valve disease requiring surgery or severe tricuspid regurgitation (per ASE guidelines; core lab assessment)
  • Aortic valve disease requiring surgery
  • Moderate or severe aortic valve stenosis or regurgitation
  • Aortic valve prosthesis
  • Fluoroscopic or echocardiographic evidence of severe aortic arch calcification, mobile aortic atheroma, intracardiac mass, thrombus, or vegetation
  • Need for any cardiovascular surgery (other than for MV disease)
  • Active endocarditis
  • Anatomical pathology/constraints preventing appropriate access/implant of the AccuCinch System (e.g., femoral arteries will not support an 18F system)
  • Known allergy to nickel, polyester, or polyethylene
  • Active infections requiring current antibiotic therapy
  • Currently participating in another interventional investigational study
  • Subjects in whom transesophageal echocardiography is contraindicated or high risk
  • Implant or revision of any rhythm management device (CRT or CRT-D) or implantable cardioverter-defibrillator within 1 month
  • Absence of CRT with Class I indication criteria for biventricular pacing
  • Subjects on high dose steroids or immunosuppressant therapy
  • Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with guideline directed medical therapy) and follow-up visits
  • Patient (or legal guardian) unable or unwilling to provide written, informed consent before study enrollment
  • Pregnant or planning pregnancy within next 12 months. Note: Female patients of childbearing potential need to have a negative pregnancy test performed within 14 days prior to intervention and be adherent to an accepted method of contraception

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 ClinicalTrials.gov identifier (NCT number): NCT03183895


Contacts
Layout table for location contacts
Contact: Michael Zapien, MS, CCRA 408-727-1105 ext 204 mzapien@ancoraheart.com
Contact: Rossella Mercuri r.mercuri@meditrial.eu

Locations
Layout table for location information
Belarus
Republican Scientific and Practical Centre of Cardiology Not yet recruiting
Minsk, Belarus, 220036
Contact: Alena Kurlianskaya, MD, PhD         
Principal Investigator: Alena Kurlianskaya, MD, PhD         
Czechia
Na Homolce Hospital Not yet recruiting
Prague, Czechia, 15030
Contact: Liz Coling         
Principal Investigator: Petr Neuzil         
Principal Investigator: Vivek Reddy, MD         
France
Clinique Pasteur Not yet recruiting
Toulouse, France
Contact: Nicolas Dumonteil       ndumonteil@clinique-pasteur.com   
Principal Investigator: Nicolas Dumonteil         
Italy
Ospedale San Raffaele Not yet recruiting
Milano, Italy
Contact: Azeem Latib       alatib@gmail.com   
Principal Investigator: Azeem Latib         
Netherlands
St. Antonius Ziekenhuis Recruiting
Nieuwegein, Netherlands
Contact: Mike Bosschaert       m.bosschaert@antoniusziekenhuis.nl   
Principal Investigator: B.J.W.M. Rensing         
Erasmus Medical Center Not yet recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Nicolas van Mieghem         
Principal Investigator: Nicolas van Mieghem         
United Kingdom
Royal Victoria Hospital, Belfast Trust Not yet recruiting
Belfast, United Kingdom
Contact: Mark Spence       marks.spence@belfasttrust.hscni.net   
Principal Investigator: Mark Spence         
Royal Brompton & Harefield NHS Trust Not yet recruiting
London, United Kingdom
Contact: Lauren Kelly       l.kelly2@rbht.nhs.uk   
Principal Investigator: Rob Smith         
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
Layout table for investigator information
Study Director: Michael Zapien, MS, CCRA Ancora Heart, Inc.

Layout table for additonal information
Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT03183895     History of Changes
Other Study ID Numbers: 4631
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Cardiomyopathies
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases