Safety and Performance Study of the Harpoon Mitral Valve Repair System

Mitral Valve Insufficiency Clinical Trial

Official title:

Safety and Performance Study of the Harpoon Medical Device in Patients With Degenerative Mitral Regurgitation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03285724
• Other study ID #: HMEFS-2000
• Status: Terminated
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: April 20, 2018

Study information

• Verified date: November 2019
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The device is designed to reduce the degree of mitral regurgitation by delivering and anchoring artificial chordae tendineae to the affected mitral valve leaflet(s) in a beating heart.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: April 20, 2018
• Est. primary completion date: June 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• EuroScore (for mitral valve repair) > 8%

• Patients with contraindications to Transesophageal echocardiography

• Severe left or right ventricular dysfunction

• NYHA Class IV

• Renal insufficiency CKD stage 3b or worse (GFR < 45 ml/min/1.73 m2)

• Patient is participating in another clinical study for which follow-up is currently ongoing. (Co-enrollment in an investigational device or interventional study)

• Patient with non-cardiac co-morbidities and life expectancy < 1 year

• Patient has a condition or conditions that, in the opinion of the Investigator, preclude participation, including willingness to comply with all follow-up procedures

Related Conditions & MeSH terms

• Mitral Valve Insufficiency
• Mitral Valve Prolapse
• Mitral Valve Regurgitation
• Prolapse

Intervention

Device:
• Harpoon Artificial ePTFE Chords
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.

Locations

Country	Name	City	State
Poland	Jagiellonian University	Krakow
Poland	Instytut of Kardiologii & Transplantology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subject's Severity of Mitral Regurgitation Over Time	Severity of mitral regurgitation at 6 months, 12 months and 24 months follow-up shall be tracked and recorded	6 Months, 12 Months, and 24 Months
Secondary	Subject's Freedom From Serious Adverse Events Over Time	Freedom from Serious Adverse Events (SAEs) at 6 months, 12 months and 24 months follow-up shall be tracked and recorded	6 Months, 12 Months, and 24 Months