Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair (MEMO3D)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group USA, Inc.
ClinicalTrials.gov Identifier:
NCT00567853
First received: December 4, 2007
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to collect data on the effectiveness and clinical outcomes of the MEMO 3D Annuloplasty ring as used for mitral valve repair.


Condition Intervention Phase
Mitral Valve Regurgitation
Device: Implantation of the MEMO 3D Annuloplasty Ring
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation Of The Sorin 3D Annuloplasty Ring For Mitral Repair

Further study details as provided by Sorin Group USA, Inc.:

Primary Outcome Measures:
  • The percentage of patients with successful repair at 6 months. [ Time Frame: One Year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Freedom from re-operation at 12 months. Preoperative and postoperative mitral valve regurgitation and LV dimensions and mass assessed by echocardiography. Actuarial survival and freedom from clinical events at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: August 2007
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MEMO 3D ring
All patients in the study will be implanted with the MEMO 3D ring
Device: Implantation of the MEMO 3D Annuloplasty Ring
Implantation of the MEMO 3D Annulopalsty Ring for mitral valve repair.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is 18 years old or older
  • An annuloplasty ring is indicated for reinforcement of a dysfunctional or diseased native mitral valve according to the current medical practice for valvular repair at each site.
  • The subject is able to return for all follow-up evaluations of the study.

Exclusion Criteria:

  • The subject or subject's legal representative is unwilling to sign the informed consent.
  • The subject is or will be participating in another medical device or drug clinical trial.
  • The subject is a minor, prisoner, institutionalized, or is unable to give informed consent.
  • The subject has a life expectance of less than 1 year.
  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 ClinicalTrials.gov identifier: NCT00567853

Locations
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63100
United States, Pennsylvania
University of Pennsylvania Presbyterian Hospital
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Sponsors and Collaborators
Sorin Group USA, Inc.
Investigators
Principal Investigator: Clark Hargrove, M.D. University of Pennsylvania Presbyterian Medical Center
  More Information

No publications provided

Responsible Party: Sorin Group USA, Inc.
ClinicalTrials.gov Identifier: NCT00567853     History of Changes
Other Study ID Numbers: MEMO3D.Reg
Study First Received: December 4, 2007
Last Updated: March 7, 2013
Health Authority: Canada: Health Canada

Keywords provided by Sorin Group USA, Inc.:
mitral valve regurgitation
mitral valve disease
mitral valve repair
mitral valve dysfunction
heart valve
valve disease
cardiac surgery

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

ClinicalTrials.gov processed this record on August 28, 2014