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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Ancora Heart, Inc.
Information provided by (Responsible Party):
Ancora Heart, Inc. Identifier:
First received: November 26, 2008
Last updated: March 8, 2017
Last verified: March 2017

Prospective single-arm study of the GDS Accucinch® System in the treatment of mitral valve regurgitation through subvalvular mitral repair.

Purpose: To demonstrate the safety, feasibility and potential efficacy of using the GDS Accucinch System to reduce mitral valve regurgitation through subvalvular mitral repair.

Condition Intervention
Mitral Regurgitation
Mitral Valve Regurgitation
Functional Mitral Regurgitation
Device: GDS Accucinch® System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GDS Accucinch® System
Patients meeting the enrollment criteria will be treated with the GDS Accucinch® System.
Device: GDS Accucinch® System
Mitral valve repair due to functional disease


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

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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00800046

Contact: Michael Zapien, MS, CCRA 408-727-1105 ext 204

Medical Care Center Hamburg University Cardiovascular Center Recruiting
Hamburg, Germany, 22527
Principal Investigator: Joachim Schofer, Prof. Dr.         
Sponsors and Collaborators
Ancora Heart, Inc.
Principal Investigator: Joachim Schofer, Prof. Dr. Medical Care Center Prof. Mathey, Prof. Schofer, GmbH
  More Information

Responsible Party: Ancora Heart, Inc. Identifier: NCT00800046     History of Changes
Other Study ID Numbers: 1436
Study First Received: November 26, 2008
Last Updated: March 8, 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

Keywords provided by Ancora Heart, Inc.:
Mitral valve
Mitral regurgitation
Functional mitral regurgitation
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 processed this record on May 25, 2017