Observational Registry on the HARPOON Device (REPLICATE)

Edwards Lifesciences

Status: Terminated

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

Treatments: Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04393779

2019-12

Details and patient eligibility

About

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

Full description

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

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

26 participants in 1 patient group

HARPOON™ MVRS

Other group

Description:

Subjects who were treated with the HARPOON MVRS.

Treatment:

Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)