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Multicenter International Trial Ring AnnulopLasty

NCT00727012 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2019-02-04

No results posted yet for this study

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

Interventions

DEVICE

mitral valve repair (SJM® Rigid Saddle Ring)

mitral valve repair due to mitral degenerative or functional disease

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Raffaele De Simone, Prof. Dr. · Heidelberg University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00727012 on ClinicalTrials.gov