MitraClip NT System Post-marketing Surveillance Study - Japan

Mitral Regurgitation Clinical Trial

— MitraClip NT  

Official title:

MitraClip NT System Post -Marketing Surveillance Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03500692
• Other study ID #: 17-519
• Status: Completed
• Start date: April 2, 2018
• Est. completion date: March 23, 2022

Study information

• Verified date: June 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 23, 2022
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Refer to MitraClip IFU

Exclusion Criteria: Refer to MitraClip IFU

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency
• Mitral Valve Regurgitation

Intervention

Device:
• MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System

Locations

Country	Name	City	State
Japan	Hyogo Prefectural Amagasaki General Medical Center	Amagasaki	Hyogo
Japan	Asahikawa Medical University Hospital	Asahikawa	Hokkaido
Japan	Juntendo University Hospital	Bunkyo	Tokyo
Japan	The University of Tokyo Hospital	Bunkyo	Tokyo
Japan	Mitsui Memorial Hospital	Chiyoda	Tokyo
Japan	Sakakibara Heart Institute	Fuchu	Tokyo
Japan	Kyushu University Hospital	Fukuoka-shi	Fukuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hyogo Brain and Heart Center	Himeji	Hyogo
Japan	Tokai University Hospital	Isehara	Kanagawa
Japan	Teikyo University Hospital	Itabashi	Tokyo
Japan	Shonan Kamakura General Hospital	Kamakura	Kanagawa
Japan	St. Marianna Medical University Hospital	Kawasaki	Kanagawa
Japan	Kishiwada Tokushukai Hospital	Kishiwada	Osaka
Japan	Kokura Memorial Hospital	Kitakyushu	Fukuoka
Japan	Saiseikai Kumamoto Hospital	Kumamoto-shi	Kumamoto
Japan	Kurashiki Central Hospital	Kurashiki	Okayama
Japan	University Hospital Kyoto Prefectural University of Medicine	Kyoto-shi	Kyoto
Japan	New Tokyo Hospital	Matsudo	Chiba
Japan	Ehime Prefectural Central Hospital	Matsuyama	Ehime
Japan	Miyazaki Medical Association Hospital	Miyazaki-shi	Miyazaki
Japan	Iwate Medical University Hospital	Morioka	Iwate
Japan	Nagoya Heart Center	Nagoya	Aichi
Japan	The Sakakibara Heart Institute of Okayama	Okayama-shi	Okayama
Japan	Osaka City University Hospital	Osaka-shi	Osaka
Japan	Osaka General Medical Center	Osaka-shi	Osaka
Japan	Hokkaido University Hospital	Sapporo	Hokkaido
Japan	Sendai Kousei Hospital	Sendai-shi	Miyagi
Japan	Keio University Hospital	Shinjuku-Ku	Tokyo
Japan	Tokyo Women's Medical University Hospital	Shinjuku-Ku	Tokyo
Japan	Shizuoka General Hospital	Shizuoka-shi	Shizuoka
Japan	National Cerebral and Cardiovascular Center	Suita-shi	Osaka
Japan	Osaka University Hospital	Suita-shi	Osaka
Japan	Tokushima Red Cross Hospital	Tokushima
Japan	Toyama University Hospital	Toyama-shi	Toyama
Japan	Toyohashi Heart Center	Toyohashi	Aichi
Japan	University of Tsukuba Hospital	Tsukuba	Ibaraki
Japan	Tokyo Bay Urayasu Ichikawa Medical Center	Urayasu	Chiba
Japan	Saiseikai Yokohamashi Tobu Hospital	Yokohama	Kanagawa
Japan	Tottori University Hospital	Yonago	Tottori

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Medical Devices	Abbott

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Single Leaflet Device Attachment (SLDA) Rate	SLDA is defined as the attachment of one mitral leaflet to the MitraClip® Device	up to 30 Days
Primary	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