MitraClip NT System Post-marketing Surveillance Study - Japan
- Conditions
- Mitral RegurgitationMitral Valve Regurgitation
- Interventions
- Device: MitraClip NT System
- Registration Number
- NCT03500692
- Lead Sponsor
- Abbott Medical Devices
- 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
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Refer to MitraClip IFU
Refer to MitraClip IFU
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description MitraClip NT System MitraClip NT System Percutaneous mitral valve repair using MitraClip NT System
- 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
Trial Locations
- Locations (40)
Kokura Memorial Hospital
🇯🇵Kitakyushu, Fukuoka, Japan
Asahikawa Medical University Hospital
🇯🇵Asahikawa, Hokkaido, Japan
New Tokyo Hospital
🇯🇵Matsudo, Chiba, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
🇯🇵Urayasu, Chiba, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Mitsui Memorial Hospital
🇯🇵Chiyoda, Tokyo, Japan
Tokyo Women's Medical University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
The University of Tokyo Hospital
🇯🇵Bunkyo, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjuku-Ku, Tokyo, Japan
Juntendo University Hospital
🇯🇵Bunkyo, Tokyo, Japan
University of Tsukuba Hospital
🇯🇵Tsukuba, Ibaraki, Japan
Iwate Medical University Hospital
🇯🇵Morioka, Iwate, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
Nagoya Heart Center
🇯🇵Nagoya, Aichi, Japan
Toyohashi Heart Center
🇯🇵Toyohashi, Aichi, Japan
Hokkaido University Hospital
🇯🇵Sapporo, Hokkaido, Japan
Hyogo Brain and Heart Center
🇯🇵Himeji, Hyogo, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Amagasaki, Hyogo, Japan
Tokai University Hospital
🇯🇵Isehara, Kanagawa, Japan
Saiseikai Kumamoto Hospital
🇯🇵Kumamoto-shi, Kumamoto, Japan
Shonan Kamakura General Hospital
🇯🇵Kamakura, Kanagawa, Japan
St. Marianna Medical University Hospital
🇯🇵Kawasaki, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital
🇯🇵Yokohama, Kanagawa, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto-shi, Kyoto, Japan
Sendai Kousei Hospital
🇯🇵Sendai-shi, Miyagi, Japan
The Sakakibara Heart Institute of Okayama
🇯🇵Okayama-shi, Okayama, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki, Okayama, Japan
Miyazaki Medical Association Hospital
🇯🇵Miyazaki-shi, Miyazaki, Japan
Osaka City University Hospital
🇯🇵Osaka-shi, Osaka, Japan
Kishiwada Tokushukai Hospital
🇯🇵Kishiwada, Osaka, Japan
Osaka General Medical Center
🇯🇵Osaka-shi, Osaka, Japan
National Cerebral and Cardiovascular Center
🇯🇵Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka, Saitama, Japan
Shizuoka General Hospital
🇯🇵Shizuoka-shi, Shizuoka, Japan
Sakakibara Heart Institute
🇯🇵Fuchū, Tokyo, Japan
Teikyo University Hospital
🇯🇵Itabashi, Tokyo, Japan
Tottori University Hospital
🇯🇵Yonago, Tottori, Japan
Toyama University Hospital
🇯🇵Toyama-shi, Toyama, Japan
Tokushima Red Cross Hospital
🇯🇵Tokushima, Japan