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.
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.
Study Type
OBSERVATIONAL
Enrollment
500
Percutaneous mitral valve repair using MitraClip NT System
Single Leaflet Device Attachment (SLDA) Rate
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
Time frame: up to 30 Days
No of Participants With Acute Procedural Success (APS)
APS is defined as resulting MR reduction to ≤ 2+ per echocardiographic assessment. Mitral regurgitation severity is determined based on the American Society of Echocardiography (ASE) Recommendations for Evaluation of The Severity of Native Valvular Regurgitation with Two-Dimensional and Doppler Echocardiography. MR severity grade was assessed by the core lab using the transthoracic echocardiogram (TTE) at baseline, discharge and subsequent follow-up visits. The severity of MR is determined by the amount of blood being pushed back into the left atrium when it should be circulating through the left ventricle with each heart beat. MR severity is typically classified as mild (grade 1+), moderate (grade 2+), moderate to severe (grade 3+) or severe (grade 4+).
Time frame: up to 7 days (Discharge visit) from Procedure date
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Nagoya Heart Center
Nagoya, Aichi-ken, Japan
Toyohashi Heart Center
Toyohashi, Aichi-ken, Japan
New Tokyo Hospital
Matsudo, Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, Japan
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