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Trial record 2 of 8 for:    ancora heart

An Early Feasibility Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF 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: NCT03533517
Recruitment Status : Recruiting
First Posted : May 23, 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 to evaluate the AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF).

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 Evaluation of the AccuCinch® Ventricular Repair System in Patients With Heart Failure and Reduced Ejection Fraction (HFrEF) - The CorCinch-HFrEF Study
Actual Study Start Date : August 23, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: AccuCinch® Ventricular Repair System Device: AccuCinch® Ventricular Repair
AccuCinch® Ventricular Repair System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)




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
  • Ejection Fraction: ≥20 and ≤40%
  • LV end-diastolic diameter ≥55 mm
  • Symptom Status: NYHA III-IVa (i.e., ambulatory)
  • Treatment and compliance with optimal guideline directed medical and device-based therapies for heart failure (unless contraindicated or intolerant) for at least 3 months and stable doses for 1 month with stable defined as no more than 100% increase or 50% decrease of total daily doses.
  • Patients with left bundle branch block pattern and QRS duration >150ms are required to have a CRT device for at least 3 months
  • Patients required to have an ICD are required to have ICD implant at least 1 month prior to enrollment
  • Able and willing to complete all qualifying diagnostic and functional tests and agrees to comply with study follow-up schedule

Exclusion Criteria:

  • Myocardial infarction or any percutaneous cardiovascular intervention, cardiovascular surgery, or carotid surgery within 3 months
  • Mitral regurgitation grade 3 (moderate-severe) or more
  • 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 or interventions within the next 6 months (including right heart procedures)
  • NYHA class IVb (i.e., non-ambulatory)
  • Significant RV dysfunction (TAPSE < 14)
  • Severe tricuspid regurgitation
  • 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
  • Anatomical pathology or constraints preventing appropriate access/implant of the AccuCinch® Ventricular Repair System (e.g., femoral arteries will not support an 20F system)
  • 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 any stroke within the prior 3 months or Modified Rankin Scale ≥ 4 disability from any prior stroke
  • 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): NCT03533517


Contacts
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Contact: Michael Zapien, MS, CCRA 4087271105 mzapien@ancoraheart.com
Contact: Judit Adorjan 4087271105 jadorjan@ancoraheart.com

Locations
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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, Nebraska
Nebraska Heart Institute / Nebraska Heart Hospital Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Corey Godfrey, MSPE, CCRC, CEP    402-328-3930    cgodfrey@neheart.com   
Principal Investigator: Steve Martin, MD         
Principal Investigator: James Wudel, 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, New York
Montefiore Medical Center Not yet recruiting
Bronx, New York, United States, 10467
Contact: Giora Weisz, MD         
Principal Investigator: Giora Weisz, MD         
Principal Investigator: Ulrich Jorde, MD         
Mt. Sinai Not yet recruiting
New York, New York, United States, 10029
Contact: Besty Ellsworth, MSN, ANP         
Principal Investigator: Vivek Reddy, MD         
Columbia University Medical Center/NYPH Not yet recruiting
New York, New York, United States, 10032
Contact: Lauren Privitera, MPH    212-342-3488    lp2183@cumc.columbia.edu   
Principal Investigator: Susheel Kodali, MD         
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         
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Kim Clinton         
Principal Investigator: Howard Herrmann, 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: NCT03533517     History of Changes
Other Study ID Numbers: 5017
First Posted: May 23, 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
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly