Safety and Performance Study of the Harpoon Mitral Valve Repair System

NCT03285724 | Terminated Results FDA Device

• 1 other identifier: HMEFS-2000
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 2

Brief Summary

The primary objective of this study is to evaluate the safety and performance of the Harpoon Medical Device. It is anticipated, that the Harpoon Medical Device will provide advantages over current surgical interventions including: 1) a small minimally invasive incision, 2) no sternotomy, 3) no cardiopulmonary bypass, 4) no aortic manipulation, 5) a direct path to the valve plane, 6) performed on a beating heart, 7) real-time TEE-guided ePTFE cordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Conditions

Mitral Valve Regurgitation; Mitral Valve Prolapse; Mitral Valve Insufficiency

Keywords

Mitral Valve Repair; Transapical; artificial chordae; bi-leaflet prolapse; anterior prolapse; posterior prolapse

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Procedural Success During the First 30 Days

  To demonstrate that the Harpoon Medical Device performs as designed and can successfully implant one or more ePTFE artificial cords on either the anterior, posterior, or both leaflets of the mitral valve via a small left thoracotomy on the beating heart and reduce mitral regurgitation from "severe" to less than or equal to "moderate" at the conclusion of the procedure and at 30 days post-procedure.

  Procedure, discharge, and 30 days

• Number of Subjects With Freedom From Serious Adverse Events (SAE) During the First 30 Days

  Procedure freedom from Serious Adverse Events (SAEs) during the procedure, at discharge, and at 30 days follow-up shall be tracked and recorded.

  Procedure, Discharge and 30 Days

Secondary Outcomes (2)

• Subject's Severity of Mitral Regurgitation Over Time

  6 Months, 12 Months, and 24 Months

• Subject's Freedom From Serious Adverse Events Over Time

  6 Months, 12 Months, and 24 Months

Study Arms (1)

Harpoon Medical Transapical device TSD-5

EXPERIMENTAL

This is a prospective, single arm, nonrandomized, early feasibility study to evaluate the safety and performance of the Harpoon Medical Device.

Device: Harpoon Artificial ePTFE Chords

Interventions

Harpoon Artificial ePTFE Chords DEVICE

The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.

Harpoon Medical Transapical device TSD-5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Patient referred for mitral valve surgery
• Presence of severe MR as read on an echocardiographic study performed within 60 days prior to procedure.
• Estimated post-ePTFE cordal implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
• Degenerative mitral valve disease associated with anterior, bileaflet, or posterior leaflet prolapse
• 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
• Women of child-bearing potential have a negative pregnancy test

You may not qualify if:

• Age \< 18 years
• Infective endocarditis
• History of Mediastinal Radiation
• Inflammatory (rheumatic) valve disease
• Requirement for concomitant cardiac surgery (e.g., coronary artery bypass grafting (CABG), aortic valve surgery, etc.)
• Symptomatic coronary artery disease
• Cardiogenic shock at the time of enrollment
• ST segment elevation myocardial infarction requiring intervention within 30 days prior to enrollment
• Evidence of cirrhosis or hepatic synthetic failure
• Pregnancy at the time of enrollment (women of child bearing age should have negative pregnancy within 14 days of surgery)
• Severe pulmonary hypertension (PA systolic pressure \> 70 mmHg)
• Previous cardiac surgery, or surgery on the left pleural space
• Left ventricular, atrial or appendage thrombus
• Severely calcified mitral leaflets
• Recent stroke (\< 6 months) with permanent impairment

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

Jagiellonian University

Krakow, Poland

Location

Instytut of Kardiologii & Transplantology

Warsaw, 04-628, Poland

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency; Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Heart Valve Prolapse

Results Point of Contact

• Title: Andrey Nersesov, Sr. Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Andrey_Nersesov@edwards.com

949-250-2500

Study Officials

• Krzysztof Bartus, MD PhD

  Jagiellonian University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: May 16, 2017
• Primary Completion: June 16, 2017
• Study Completion: April 20, 2018
• Last Updated: November 19, 2019
• Results First Posted: October 14, 2019

Record last verified: 2019-11

Locations

PL (2)