Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND) - ASCEND

Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,0 sites42 target enrollmentOctober 5, 2020

ConditionsSevere Degenerative Mitral Regurgitation due to Mid-segment Posterior Leaflet Prolapse

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Severe Degenerative Mitral Regurgitation due to Mid-segment Posterior Leaflet Prolapse
Sponsor: Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,
Enrollment: 42
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 5, 2020

End Date

December 1, 2022

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Harpoon Medical, an indirect-wholly owned subsidiary of Edwards Lifesciences Corporation, Edwards Lifesciences,

Eligibility Criteria

Inclusion Criteria

•1\. Subject is \= 18 years old
•2\. Presence of severe MR as read on a transthoracic echocardiographic study
•3\. Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension approximate leaflet to gap ratio of 2:1\) based on the judgment of the patient eligibility committee and the operating surgeon
•4\. Degenerative mitral valve disease with mid\-segment P2 prolapse
•5\. Patient is able to sign informed consent and able to return for follow\-up and is capable of participating in all testing associated with this clinical investigation

Exclusion Criteria

•1\. Patient is of the age where further growth is expected
•2\. Active endocarditis
•3\. Left ventricular or left atrial appendage thrombus
•4\. Severe mitral annular and/or leaflet calcification
•5\. Cannot tolerate procedural anticoagulation or post\-procedure antiplatelet regimen
•6\. Mitral stenosis
•7\. Functional Mitral Valve disease
•8\. Previous mitral valve replacement surgery
•9\. Fragile or thinning apex
•10\. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)