N/A
Completed N=500
MitraClip NT System Post-marketing Surveillance Study - Japan
Mitral Regurgitation · Mitral Valve Regurgitation
Source: ClinicalTrials.gov NCT03500692 ↗
Enrolled (actual)
500
Serious AEs
64.4%
Results posted
Apr 2021
Primary outcomePrimary: Single Leaflet Device Attachment (SLDA) Rate — 1.21 percentage of SLDAs
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Single Leaflet Device Attachment (SLDA) Rate |
1.21 | — |
| PRIMARY No of Participants With Acute Procedural Success (APS) |
452 | — |
Eligibility Criteria
Inclusion Criteria: Refer to MitraClip IFU
Exclusion Criteria: Refer to MitraClip IFU
Data sourced from ClinicalTrials.gov (NCT03500692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.