MitraClip NT System Post-marketing Surveillance Study - Japan
MitraClip NT
MitraClip NT System Post -Marketing Surveillance Study
1 other identifier
observational
500
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2018
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedStudy Start
First participant enrolled
April 2, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2019
CompletedResults Posted
Study results publicly available
April 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2022
CompletedJuly 23, 2024
June 1, 2024
12 months
March 30, 2018
January 18, 2021
June 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Single Leaflet Device Attachment (SLDA) Rate
SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device
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+).
up to 7 days (Discharge visit) from Procedure date
Study Arms (1)
MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System
Interventions
Percutaneous mitral valve repair using MitraClip NT System
Eligibility Criteria
Post-marketing Surveillance will consecutively register patients with moderate to severe and severe mitral regurgitation (3+ and 4+ MR) in whom a MitraClip implant was attempted.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Medical Deviceslead
- Abbottcollaborator
Study Sites (40)
Nagoya Heart Center
Nagoya, Aichi-ken, 461-0045, Japan
Toyohashi Heart Center
Toyohashi, Aichi-ken, 441-8530, Japan
New Tokyo Hospital
Matsudo, Chiba, 270-2232, Japan
Tokyo Bay Urayasu Ichikawa Medical Center
Urayasu, Chiba, 279-0001, Japan
Ehime Prefectural Central Hospital
Matsuyama, Ehime, 790-0024, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, 812-8582, Japan
Kokura Memorial Hospital
Kitakyushu, Fukuoka, 802-8555, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, 078-8510, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648, Japan
Hyogo Prefectural Amagasaki General Medical Center
Amagasaki, Hyōgo, 660-8550, Japan
Hyogo Brain and Heart Center
Himeji, Hyōgo, 670-0981, Japan
University of Tsukuba Hospital
Tsukuba, Ibaraki, 305-8576, Japan
Iwate Medical University Hospital
Morioka, Iwate, 020-8505, Japan
Tokai University Hospital
Isehara, Kanagawa, 259-1193, Japan
Shonan Kamakura General Hospital
Kamakura, Kanagawa, 247-8533, Japan
St. Marianna Medical University Hospital
Kawasaki, Kanagawa, 216-8511, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, 230-8765, Japan
Saiseikai Kumamoto Hospital
Kumamoto, Kumamoto, 861-4193, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566, Japan
Sendai Kousei Hospital
Sendai, Miyagi, 980-0873, Japan
Miyazaki Medical Association Hospital
Miyazaki, Miyazaki, 880-0834, Japan
Kurashiki Central Hospital
Kurashiki, Okayama-ken, 710-8602, Japan
The Sakakibara Heart Institute of Okayama
Okayama, Okayama-ken, 700-0804, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, 596-0042, Japan
Osaka City University Hospital
Osaka, Osaka, 545-8586, Japan
Osaka General Medical Center
Osaka, Osaka, 558-8558, Japan
Osaka University Hospital
Suita-shi, Osaka, 565-0871, Japan
National Cerebral and Cardiovascular Center
Suita-shi, Osaka, 565-8565, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, 350-1298, Japan
Shizuoka General Hospital
Shizuoka, Shizuoka, 420-8527, Japan
Juntendo University Hospital
Bunkyo, Tokyo, 113-8431, Japan
The University of Tokyo Hospital
Bunkyo, Tokyo, 113-8655, Japan
Mitsui Memorial Hospital
Chiyoda City, Tokyo, 101-8643, Japan
Sakakibara Heart Institute
Fuchū, Tokyo, 183-0003, Japan
Keio University Hospital
Shinjuku-Ku, Tokyo, 160-8582, Japan
Tokyo Women's Medical University Hospital
Shinjuku-Ku, Tokyo, 162-8666, Japan
Teikyo University Hospital
tabashi City, Tokyo, 173-8606, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
Toyama University Hospital
Toyama, Toyama, 930-0194, Japan
Tokushima Red Cross Hospital
Tokushima, 773-8502, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sripad Bellary
- Organization
- Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 18, 2018
Study Start
April 2, 2018
Primary Completion
March 31, 2019
Study Completion
March 23, 2022
Last Updated
July 23, 2024
Results First Posted
April 15, 2021
Record last verified: 2024-06