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A Study of Percutaneous Treatment of Mitral Regurgitation Using the AccuCinch® System

This study is currently recruiting participants.
Verified November 2017 by Ancora Heart, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00800046
First Posted: December 1, 2008
Last Update Posted: November 20, 2017
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.
Information provided by (Responsible Party):
Ancora Heart, Inc.
  Purpose

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.


Condition Intervention
Mitral Regurgitation Mitral Valve Regurgitation Functional Mitral Regurgitation Device: AccuCinch® Ventriculoplasty System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Percutaneous Treatment of Mitral Regurgitation Using the AccuCinch® System

Further study details as provided by Ancora Heart, Inc.:

Primary Outcome Measures:
  • Safety through 30 days and reduction in MR acutely and at 30 days. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • Safety and reduction in MR at 1 year. [ Time Frame: 1 year ]

Estimated Enrollment: 40
Study Start Date: November 2008
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AccuCinch® Ventriculoplasty System
Patients meeting the enrollment criteria will be treated with the AccuCinch® Ventriculoplasty System.
Device: AccuCinch® Ventriculoplasty System
Mitral valve repair due to functional disease

  Eligibility

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.


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

Inclusion Criteria:

  • Patients with mitral regurgitation grade of ≥ 2+ (Germany) and ≥ 3+(Canada)
  • Ejection Fraction ≥ 30%
  • Patient is eligible for surgical mitral valve repair or replacement
  • Confirmation by the Medical Monitor that patient has met all eligibility criteria and no exclusion criterion
  • The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent

Exclusion Criteria:

  • Myocardial infarction within 90 days of the intended treatment with the device
  • Prior surgical, transcatheter, or percutaneous mitral valve intervention
  • Any intervention for coronary artery disease (CAD) within the last 3 months prior to treatment, or known requirement for revascularization within the next 12 months
  • Hemodynamic instability or the need for emergent surgery
  • NYHA Class IV symptoms of heart failure
  • History of bacterial endocarditis
  • History of bleeding diathesis or coagulopathy
  • History of stroke within the prior 6 months
  • Any angiographic or clinical evidence that the investigator feels would place the patient at increased risk with the placement of the device or concurrent medical condition with a life expectancy of less than 12 months
  • Co-morbid conditions that place the subject at an unacceptable surgical risk or any contraindication to mitral valve surgery
  • Subjects require concomitant cardiac surgical repair such as other mitral repair techniques, coronary artery bypass graft (CABG), aortic valve replacement, tricuspid repair or replacement, left ventricular remodeling surgery and congenital repair
  • Female patients who are pregnant, of child bearing potential or lactating
  • Patients who are unable or unwilling to comply with the follow-up schedule
  Contacts and Locations
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): NCT00800046


Contacts
Contact: Michael Zapien, MS, CCRA 408-727-1105 ext 204 mzapien@ancoraheart.com

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Markus Vertesich       markus.vertesich@meduniwien.ac.at   
Principal Investigator: Irene Lang         
Germany
University Hospital Freiburg-Bad Krozingen Recruiting
Bad Krozingen, Germany
Contact: Stefanie Waldmann-Kittler       tefanie.Waldmann-Kittler@universitaets-herzzentrum.de   
Principal Investigator: Jürgen Rothe         
Immanuel Klinikum Bernau Herzzentrum Brandenburg Recruiting
Bernau, Germany
Contact: Daniela Bettin       d.bettin@immanuel.de   
Principal Investigator: Christian Bütter         
St.-Johannes-Hospital Recruiting
Dortmund, Germany
Contact: Rüdiger Gebauer         
Principal Investigator: Helge Möllmann         
Universitätsklinikum Düsseldorf Recruiting
Düsseldorf, Germany
Contact: Rabea Wagstaff       Rabea.Wagstaff@med.uni-duesseldorf.de   
Principal Investigator: Ralf Westenfeld         
ardiovascular Center Frankfurt Recruiting
Frankfurt, Germany
Contact: Sabine de Bruijn       s.debruijn@cvcfrankfurt.de   
Principal Investigator: Horst Sievert         
Medical Care Center Hamburg University Cardiovascular Center Not yet recruiting
Hamburg, Germany, 22527
Contact: Kerstin Flint       flint@herz-hh.de   
Principal Investigator: Joachim Schofer         
Herzzentrum Krefeld Niederrhein Recruiting
Krefeld, Germany
Contact: Alexander Bufe       alexander.bufe@helios-kliniken.de   
Principal Investigator: Alexander Bufe         
Universitäres Herzzentrum Lübeck Not yet recruiting
Lübeck, Germany
Contact: Roza Meyer-Saraei       Roza.Meyer-Saraei@uksh.de   
Principal Investigator: Steffen Desch         
Krankenhaus der Barmherzigen Brüder Not yet recruiting
Trier, Germany
Contact: Silke Plattfaut       s.plattfaut@bk-trier.de   
Principal Investigator: Karl Eugen Hauptmann         
Sponsors and Collaborators
Ancora Heart, Inc.
Investigators
Principal Investigator: Joachim Schofer, Prof. Dr. Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
  More Information

Responsible Party: Ancora Heart, Inc.
ClinicalTrials.gov Identifier: NCT00800046     History of Changes
Other Study ID Numbers: 1436
First Submitted: November 26, 2008
First Posted: December 1, 2008
Last Update Posted: November 20, 2017
Last Verified: November 2017

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

Keywords provided by Ancora Heart, Inc.:
Mitral valve
Mitral regurgitation
Functional mitral regurgitation
MR
FMR
Heart valve
Mitral valve insufficiency
Valve repair
Valve disorder
Cardiac surgery

Additional relevant MeSH terms:
Mitral Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases