Multicenter International Trial Ring AnnulopLasty

NCT00727012 | Completed

• 1 other identifier: CS06003RG
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is a multicenter, prospective non-randomized observational study without concurrent or matched controls in which 150 patients receiving an SJM® Rigid Saddle Ring will be included. The primary objective of the study is to demonstrate the effectiveness of the SJM® Rigid Saddle Ring when used in mitral valve repair procedures.

Conditions

Mitral Valve Insufficiency

Keywords

mitral valve; heart valve; valve repair; valve disorder; valve disease; cardiac surgery

Outcome Measures

Primary Outcomes (2)

• Change in ERO (Effective Regurgitant Orifice) in cm2 calculated with PISA method at 6 months and at patient discharge compared to baseline (pre-operative).

  6 months

• NYHA class

  6 months

Secondary Outcomes (1)

• adverse events rates

  6 months

Study Arms (1)

SJM® Rigid Saddle Ring

OTHER

The SJM® Rigid Saddle Ring is an annuloplasty ring comprised of a titanium core surrounded by a double-velour, polyester fabric sewing cuff.

Device: mitral valve repair (SJM® Rigid Saddle Ring)

Interventions

mitral valve repair (SJM® Rigid Saddle Ring) DEVICE

mitral valve repair due to mitral degenerative or functional disease

SJM® Rigid Saddle Ring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requiring a mitral valve repair due to mitral degenerative or functional disease (Note: Patients that underwent concomitant procedures, e.g. coronary artery bypass grafting, are eligible for this study);
• Patient (or legal guardian) has signed a study specific informed consent form agreeing to the data collection and follow-up requirements;
• Patients are at least 18 years old.

You may not qualify if:

• Patient requires replacement of the aortic, tricuspid or pulmonary valve or has a pre-existing prosthetic valve;
• Patient is pregnant or nursing;
• Patient has active endocarditis;
• Patient is actively participating in another study of an investigational drug or device;
• Patients unavailable to follow-up visit (abroad residents, patients affected by neurological disorders...);
• Patients who are intravenous drug abusers, alcohol abusers, prison inmates or unable to give informed consent;
• Patients with a major non-cardiac evolving disease;
• Patients with a life expectancy less than 1 year;
• Patients are known to be noncompliant or are unlikely to complete the study;
• Any case in which mitral annuloplasty rings are not indicated;

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

University of Heidelberg

Heidelberg, 69120, Germany

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Study Officials

• Raffaele De Simone, Prof. Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: August 1, 2008
• Study Start: June 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

DE (1)