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Completed

NCT Number: NCT03500692

MitraClip NT System Post-marketing Surveillance Study - Japan

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.

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Key information

Conditions

Mitral Regurgitation Cardiovascular Diseases Heart Diseases Heart Valve Diseases Mitral Valve Insufficiency Mitral Valve Regurgitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya Heart Center, Nagoya, Aichi-ken, Japan

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Refer to MitraClip IFU

Exclusion criteria

Refer to MitraClip IFU

Treatment and study plan

MitraClip NT System

Device

Percutaneous mitral valve repair using MitraClip NT System

Primary outcomes

  1. 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

  2. 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+).

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Collaborators

  • Abbott

Registry information

Official study title

MitraClip NT System Post -Marketing Surveillance Study

Acronym: MitraClip NT

Important dates

Study start
2018
Primary completion
2019
Study completion
2022
First posted
Apr 18, 2018
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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