MitraClip NT System Post-marketing Surveillance Study - Japan
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About
The purpose of the MitraClip post-marketing clinical use surveillance study is to observe the frequency, type and degree of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect safety and efficacy information for evaluating the results of the clinical use.
Full description
This study is a prospective, mutli-center, single-arm post-marketing clinical use surveillance study. The Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted. Patients registered in the AVJ-514 clinical trial who received additional MitraClip procedures will be excluded from the Surveillance.
Patients will be evaluated at Baseline, Procedure, Discharge, 30 days, 1 year, 2 years and 3 years in Japanese medical centers.
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria: Refer to MitraClip IFU
Exclusion Criteria: Refer to MitraClip IFU
Trial design
500 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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