Observational Registry on the HARPOON Device

Edwards Lifesciences26 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

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

Interventions

HARPOON Beating Heart Mitral Valve Repair System (MVRS)DEVICE

Repair of the chordae tendinae in the mitral valve.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. Exclusion Criteria: * N/A

Locations (7)

Universitätsklinik Ulm

Ulm, Baden-Wurttemberg, Germany

Rhön Klinikum Kardiochirurgie

Bad Neustadt an der Saale, Bavaria, Germany

Klinikum Passau

Passau, Bavaria, Germany

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, Germany

Outcomes

Primary Outcomes

Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant

Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant

Time frame: 1 year post-implant

Data from ClinicalTrials.gov

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