Safety and Efficacy Study of the Sorin 3D Annuloplasty Ring For Mitral Repair - Full Text View

Sponsored by:	CarboMedics Inc.
Information provided by:	CarboMedics Inc.
ClinicalTrials.gov Identifier:	NCT00567853

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: MEMO 3D Annuloplasty Ring for mitral valve repair	Phase III

MedlinePlus related topics: Surgery

U.S. FDA Resources

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

Further study details as provided by CarboMedics 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:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Use of the MEMO 3D Annuloplasty Ring for repair of the mitral valve.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00567853

Contacts

Contact: Barbara P. Mathews, MSN	512-435-3602	barbara.mathews@sorin.com
Contact: John Villarreal, BS	512-435-3207	john.villarreal@sorin.com

Locations

United States, Minnesota
Minneapolis Heart Institute	Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: David Chose, BSN 612-863-3834 david.chose@allina.com
Principal Investigator: Vibhu R Kshettry, M.D.
United States, Missouri
Barnes Jewish Hospital	Recruiting
St. Louis, Missouri, United States, 63100
Contact: Tracey Guthrie 314-747-4404 guthriet@wudosis.wustl.edu
Principal Investigator: Marc Moon, M.D.
United States, Pennsylvania
University of Pennsylvania Presbyterian Hospital	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Marsha Watts, BSN 215-662-9595 marsha.watts@uphs.upenn.edu
Principal Investigator: Clark Hargrove, M.D.
Canada, Alberta
Foothills Medical Centre	Recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Marg Holland, RN, CPN(C) 403-944-4326 marg.holland@calgaryhealthregion.ca
Principal Investigator: Andrew Maitland, M.D.
Canada, Nova Scotia
Queen Elizabeth II Health Sciences Centre	Recruiting
Halifax, Nova Scotia, Canada, B3H 3A7
Contact: Janice MacIssac, BSN (902) 473-5780 macisaacje@cdha.nshealth.ca
Principal Investigator: Jeremy Wood, M.D.
Canada, Ontario
St. Michael's Hospital	Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Hwee Teoh, PhD (416) 864-6060 ext 4008 teohh@smh.toronto.on.ca
Principal Investigator: Lee Errett, MD

Sponsors and Collaborators

CarboMedics Inc.

Investigators

Principal Investigator:

Clark Hargrove, M.D.

University of Pennsylvania Presbyterian Medical Center

More Information

No publications provided

Responsible Party:	CarboMedics Inc. ( Barbara Mathews/Senior Driector Clinical and Medical Affairs )
Study ID Numbers:	MEMO3D.Reg
Study First Received:	December 4, 2007
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00567853
Health Authority:	Canada: Health Canada

Keywords provided by CarboMedics Inc.:

mitral valve regurgitation
mitral valve disease
mitral valve repair
mitral valve dysfunction

heart valve
valve disease
cardiac surgery

Study placed in the following topic categories:

Heart Diseases
Heart Valve Diseases
Mitral Valve Insufficiency

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 12, 2009