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Trial record 4 of 8 for:    ancora heart

Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study

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ClinicalTrials.gov Identifier: NCT03560167
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Ancora Heart, Inc.

Brief Summary:
This is a non-randomized, prospective, multi-center Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation.

Condition or disease Intervention/treatment Phase
Heart Failure Cardiomyopathy, Dilated Device: AccuCinch® Ventricular Repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Early Feasibility Study of the AccuCinch® Ventricular Repair System in Patients With Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation - The CorCinch-PMVI Study
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AccuCinch® Ventricular Repair System Device: AccuCinch® Ventricular Repair
AccuCinch® Ventricular Repair System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation




Primary Outcome Measures :
  1. Safety measured by device-related or procedure-related major adverse events (MAEs) [ Time Frame: 30-day ]
    Device-related or procedure-related major adverse events (MAEs)



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Study patient is at least 18-years old
  • Severity of FMR: ≥ Moderate (i.e., ≥2+, according to Stone et al Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document from the Mitral Valve Academic Research Consortium11; and 2003 ASE Guidelines for grading mitral regurgitation10)
  • Patient has had a prior surgical or percutaneous mitral repair procedure >3 months prior to enrollment
  • LV Ejection Fraction: ≥20 to ≤40%
  • Symptom Status: NYHA II-IVa (i.e., ambulatory)
  • Prescribed appropriate guideline-directed medical therapy for heart failure for at least 3 months with stable doses of diuretics, beta-blockers and ACEi or ARB for 1 month (with stable defined as no greater than 100% increase of 50% decrease in medication doses). Treatment shall include CRT and/or ICD when indicated by guidelines.
  • Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

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 replacement
  • Untreated clinically significant coronary artery disease (CAD) requiring revascularization
  • 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)
  • NYHA class IVb (i.e., non-ambulatory) or ACC/AHA Stage D heart failure
  • Fixed pulmonary artery systolic pressure >70 mmHg
  • Severe tricuspid regurgitation
  • History of any stroke within the prior 3 months or any prior stroke with 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 AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support an 20F 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
  • 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 CRT-D) prior 3 months or implantable cardioverter defibrillator within the prior 1 month
  • Subjects on high dose steroids or immunosuppressant therapy
  • Female subjects who are pregnant, of child bearing potential without a documented birth control method, 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 ClinicalTrials.gov identifier (NCT number): NCT03560167


Contacts
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Contact: Michael Zapien, MS, CCRA 4087271105 mzapien@ancoraheart.com
Contact: Sue Walsh, RN 4087271105 swalsh@ancoraheart.com

Locations
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United States, Georgia
Emory University Not yet recruiting
Atlanta, Georgia, United States, 30322
Contact: Lauren Wheeler    404-712-7623    lmwheeler@emory.edu   
Principal Investigator: Kendra Grubb, MD         
United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Anne Marie Webb, RN, BSN    502-587-4106    anne.webb@louisville.edu   
Principal Investigator: Mark Slaughter, MD         
United States, Minnesota
Minneapolis Heart Foundation Institute Not yet recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Sara Olson, RN, BSN,    612-863-7601    sara.olson@allina.com   
Principal Investigator: Paul Sorajja, MD         
United States, New Jersey
Hackensack University Medical Center Not yet recruiting
Hackensack, New Jersey, United States, 07601
Contact: Peter Canino, RN, BS, RCIS    551-996-5595    Peter.Canino@hackensackmeridian.org   
Principal Investigator: Carlos Ruiz, MD, PhD         
United States, Pennsylvania
PinnacleHealth Cardiovascular Institute Recruiting
Harrisburg, Pennsylvania, United States, 17101
Contact: Regina Holister, RN       rhollister@PINNACLEHEALTH.org   
Principal Investigator: Hemal Gada, MD         
Sub-Investigator: Mubashir Mumtaz, MD         
Penn State Health Milton S. Hershey Medical Center Not yet recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Chris Capper, RN, BSN, CCRC    717-531-5825      
Principal Investigator: Pradeep Yadav, MD         
United States, Texas
Baylor College of Medicine St. Luke's Medical Center Not yet recruiting
Houston, Texas, United States, 77020
Contact: Aline Barzilla, CCRC    832-355-3710    barzilla@bcm.edu   
Principal Investigator: Guilherme Silva, MD         
United States, Utah
Intermountain Medical Center Not yet recruiting
Salt Lake City, Utah, United States, 84109
Contact: Meredith Allen    801-507-4769    Meredith.Allen@imail.org   
Principal Investigator: Brian Whisenant, MD         
United States, Virginia
University of Virginia School of Medicine Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Linda Bailes, RN    434-982-1058    lgs2m@virginia.edu   
Principal Investigator: Scott Lim, MD         
Virginia Tech Carilion School of Medicine and Research Institute Not yet recruiting
Roanoke, Virginia, United States, 24014
Contact: Lisa Wilikerson, BS, CCRP    540-266-6658      
Principal Investigator: Jason Foerst, MD         
Principal Investigator: Rahul Sharma, MD         
United States, Washington
University of Washington Medicine Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Fatemeh Ranjbaran, RN, BSN, CCRP    206-221-9154    FRanjbaran@cardiology.washington.edu   
Sub-Investigator: Mark Reisman, MD         
Principal Investigator: Creighton Don, MD         
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
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Study Director: Michael Zapien, MS, CCRA Ancora Heart, Inc.

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Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT03560167     History of Changes
Other Study ID Numbers: 5018
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018

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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

Additional relevant MeSH terms:
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Heart Failure
Cardiomyopathies
Mitral Valve Insufficiency
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases
Cardiomegaly