MitraClip NT System Post-marketing Surveillance Study - Japan (MitraClip NT)

June 27, 2024 updated by: Abbott Medical Devices

MitraClip NT System Post -Marketing Surveillance Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokushima, Japan, 773-8502
        • Tokushima Red Cross Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 461-0045
        • Nagoya Heart Center
      • Toyohashi, Aichi, Japan, 441-8530
        • Toyohashi Heart Center
    • Chiba
      • Matsudo, Chiba, Japan, 270-2232
        • New Tokyo Hospital
      • Urayasu, Chiba, Japan, 279-0001
        • Tokyo Bay Urayasu Ichikawa Medical Center
    • Ehime
      • Matsuyama, Ehime, Japan, 790-0024
        • Ehime Prefectural Central Hospital
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Kitakyushu, Fukuoka, Japan, 802-8555
        • Kokura Memorial Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 078-8510
        • Asahikawa Medical University Hospital
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital
    • Hyogo
      • Amagasaki, Hyogo, Japan, 660-8550
        • Hyogo Prefectural Amagasaki General Medical Center
      • Himeji, Hyogo, Japan, 670-0981
        • Hyogo Brain and Heart Center
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-8576
        • University of Tsukuba Hospital
    • Iwate
      • Morioka, Iwate, Japan, 020-8505
        • Iwate Medical University Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Tokai University Hospital
      • Kamakura, Kanagawa, Japan, 247-8533
        • Shonan Kamakura General Hospital
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St. Marianna Medical University Hospital
      • Yokohama, Kanagawa, Japan, 230-8765
        • Saiseikai Yokohamashi Tobu Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 861-4193
        • Saiseikai Kumamoto Hospital
    • Kyoto
      • Kyoto-shi, Kyoto, Japan, 602-8566
        • University Hospital Kyoto Prefectural University of Medicine
    • Miyagi
      • Sendai-shi, Miyagi, Japan, 980-0873
        • Sendai Kousei Hospital
    • Miyazaki
      • Miyazaki-shi, Miyazaki, Japan, 880-0834
        • Miyazaki Medical Association Hospital
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Kurashiki Central Hospital
      • Okayama-shi, Okayama, Japan, 700-0804
        • The Sakakibara Heart Institute of Okayama
    • Osaka
      • Kishiwada, Osaka, Japan, 596-0042
        • Kishiwada Tokushukai Hospital
      • Osaka-shi, Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka-shi, Osaka, Japan, 558-8558
        • Osaka General Medical Center
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital
      • Suita-shi, Osaka, Japan, 565-8565
        • National Cerebral and Cardiovascular Center
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
    • Shizuoka
      • Shizuoka-shi, Shizuoka, Japan, 420-8527
        • Shizuoka General Hospital
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Bunkyo, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital
      • Chiyoda, Tokyo, Japan, 101-8643
        • Mitsui Memorial Hospital
      • Fuchū, Tokyo, Japan, 183-0003
        • Sakakibara Heart Institute
      • Itabashi, Tokyo, Japan, 173-8606
        • Teikyo University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Shinjuku-Ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital
    • Tottori
      • Yonago, Tottori, Japan, 683-8504
        • Tottori University Hospital
    • Toyama
      • Toyama-shi, Toyama, Japan, 930-0194
        • Toyama University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria: Refer to MitraClip IFU

Exclusion Criteria: Refer to MitraClip IFU

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System
Device: MitraClip NT System
Percutaneous mitral valve repair using MitraClip NT System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Single Leaflet Device Attachment (SLDA) Rate
Time Frame: up to 30 Days
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)
Time Frame: 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+).
up to 7 days (Discharge visit) from Procedure date

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Collaborators

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 2, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 23, 2022

Study Registration Dates

First Submitted

March 30, 2018

First Submitted That Met QC Criteria

April 10, 2018

First Posted (Actual)

April 18, 2018

Study Record Updates

Last Update Posted (Actual)

July 23, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-519

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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