MitraClip NT System Post-marketing Surveillance Study - Japan

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Refer to MitraClip IFU

Exclusion Criteria

Refer to MitraClip IFU

Primary Outcome Measures

Name	Time	Method
Single Leaflet Device Attachment (SLDA) Rate	up to 30 Days	SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
No of Participants With Acute Procedural Success (APS)	up to 7 days (Discharge visit) from Procedure date	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+).

Secondary Outcome Measures

Name	Time	Method

Locations (40): Nagoya Heart Center
🇯🇵
Nagoya, Aichi, Japan
Toyohashi Heart Center
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Toyohashi, Aichi, Japan
New Tokyo Hospital
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Matsudo, Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
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Urayasu, Chiba, Japan
Ehime Prefectural Central Hospital
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Matsuyama, Ehime, Japan
Kyushu University Hospital
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Fukuoka-shi, Fukuoka, Japan
Kokura Memorial Hospital
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Kitakyushu, Fukuoka, Japan
Asahikawa Medical University Hospital
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Asahikawa, Hokkaido, Japan
Hokkaido University Hospital
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Sapporo, Hokkaido, Japan
Hyogo Prefectural Amagasaki General Medical Center
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Amagasaki, Hyogo, Japan
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Nagoya Heart Center
🇯🇵Nagoya, Aichi, Japan