Clinical trial NCT03500692: MitraClip NT System Post-marketing Surveillance Study - Japan
Official title: MitraClip NT System Post -Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Mitral Valve Regurgitation
Keywords: Mitral Valve Regurgitation
MitraClip
MitraClip NT
Japan MitraClip NT Postmarketing Surveillance
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
Collaborators: name: Abbott
First posted: 2018-04-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria: Refer to MitraClip IFU

Exclusion Criteria: Refer to MitraClip IFU

Primary outcomes:
measure: Single Leaflet Device Attachment (SLDA) Rate
timeFrame: up to 30 Days
measure: No of Participants With Acute Procedural Success (APS)
timeFrame: up to 7 days (Discharge visit) from Procedure date
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya Heart Center
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Heart Center
state: Aichi
city: Matsudo
country: Japan
facility: New Tokyo Hospital
state: Chiba
city: Urayasu
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
state: Chiba
city: Matsuyama
country: Japan
facility: Ehime Prefectural Central Hospital
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Asahikawa
country: Japan
facility: Asahikawa Medical University Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center
state: Hyogo
city: Himeji
country: Japan
facility: Hyogo Brain and Heart Center
state: Hyogo
city: Tsukuba
country: Japan
facility: University of Tsukuba Hospital
state: Ibaraki
city: Morioka
country: Japan
facility: Iwate Medical University Hospital
state: Iwate
city: Isehara
country: Japan
facility: Tokai University Hospital
state: Kanagawa
city: Kamakura
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Kawasaki
country: Japan
facility: St. Marianna Medical University Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Saiseikai Kumamoto Hospital
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
state: Kyoto
city: Sendai-shi
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Miyazaki-shi
country: Japan
facility: Miyazaki Medical Association Hospital
state: Miyazaki
city: Kurashiki
country: Japan
facility: Kurashiki Central Hospital
state: Okayama
city: Okayama-shi
country: Japan
facility: The Sakakibara Heart Institute of Okayama
state: Okayama
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka City University Hospital
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka General Medical Center
state: Osaka
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center
state: Osaka
city: Hidaka
country: Japan
facility: Saitama Medical University International Medical Center
state: Saitama
city: Shizuoka-shi
country: Japan
facility: Shizuoka General Hospital
state: Shizuoka
city: Bunkyo
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Bunkyo
country: Japan
facility: The University of Tokyo Hospital
state: Tokyo
city: Chiyoda
country: Japan
facility: Mitsui Memorial Hospital
state: Tokyo
city: Fuchū
country: Japan
facility: Sakakibara Heart Institute
state: Tokyo
city: Itabashi
country: Japan
facility: Teikyo University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Keio University Hospital
state: Tokyo
city: Shinjuku-Ku
country: Japan
facility: Tokyo Women's Medical University Hospital
state: Tokyo
city: Yonago
country: Japan
facility: Tottori University Hospital
state: Tottori
city: Toyama-shi
country: Japan
facility: Toyama University Hospital
state: Toyama
city: Tokushima
country: Japan
facility: Tokushima Red Cross Hospital
Study officials:
References: