Observational Registry on the HARPOON Device

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2022-11-17

Brief Summary

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To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

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Detailed Description

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This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Conditions

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Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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HARPOON™ MVRS

Subjects who were treated with the HARPOON MVRS.

Group Type OTHER

HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Intervention Type DEVICE

Repair of the chordae tendinae in the mitral valve.

Interventions

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HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Repair of the chordae tendinae in the mitral valve.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.