CE Mark Study for the Harpoon Medical Device in Poland

Mitral Valve Insufficiency Clinical Trial

Official title:

Safety and Performance Study of the Harpoon Medical Transapical Suturing Device (TSD-5) in Subjects With Degenerative Mitral Regurgitation - CE Mark Study for the Harpoon Medical Device in Poland

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02432196
• Other study ID #: HMFIM -1000-PL-04
• Status: Completed
• Phase: N/A
• Start date: December 11, 2015
• Est. completion date: November 16, 2022

Study information

• Verified date: January 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and performance of the Harpoon Medical TSD-5. The Harpoon device will provide many significant 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 chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Description:

The TSD-5 is intended to secure ePTFE sutures on the mitral valve for the treatment of mitral valve disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 16, 2022
• Est. primary completion date: February 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All subjects referred for mitral valve surgery

• Presence of severe mitral regurgitation as read on an echocardiographic study performed within 60 days prior to procedure. Assessment of mitral regurgitation will be performed by the investigational site echocardiography laboratory and confirmed by the Core Echocardiography Laboratory using an integrative method.

• Age > 18 years

• 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

• Subject 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

• Able to sign informed consent

Exclusion Criteria:

• Age < 18 years

• Infective endocarditis

• Anterior or bileaflet prolapse

• Functional mitral regurgitation

• 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%

• Subjects 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 Medical Device
It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.

Locations

Country	Name	City	State
Poland	John Paul II University Hospital	Krakow
Poland	Instytut of Kardiologii & Transplantology	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Gammie JS, Wilson P, Bartus K, Gackowski A, Hung J, D'Ambra MN, Kolsut P, Bittle GJ, Szymanski P, Sadowski J, Kapelak B, Bilewska A, Kusmierczyk M, Ghoreishi M. Transapical Beating-Heart Mitral Valve Repair With an Expanded Polytetrafluoroethylene Cordal — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subject's Procedural Success During the First 30 Days	Procedural success was defined as the patient leaving the operating room with a successful implant of one or more ePTFE cords on the mitral valve and reduced mitral regurgitation from severe to	Procedure through 30 days
Primary	Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days	Subject's freedom from Serious Adverse Events during the ePTFE implantation procedure and at 30 days follow-up. Time to events were estimated by Kaplan-Meier method.	Procedure through 30 days
Primary	Subject's Serious Adverse Events (SAE) Through Discharge	Number of Participants experiencing a Serious Adverse Event (SAE) through time of Discharge.	Discharge, an average of 6 days post implant
Secondary	Subject's Severity of Mitral Regurgitation Over Time	Valvular regurgitation occurs when the valve in the heart does not close tightly allowing some of the blood that was pumped out of the heart to leak back into it. Valvular regurgitation is evaluated by echocardiography over time. It is assessed on a scale from 0 to 4, where 0 represents no regurgitation and 4 represents severe regurgitation. The numbers on the scale are reflected as follows: 0 = no leak, 1 = a trace leak, 2 = a mild leak, 3 = a moderate leak, and 4 = a severe leak.; Higher numbers on the scale show a worsening outcome.	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Secondary	Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days	Subject's freedom from Serious Adverse Events at >30 days post-implant. Time to events were estimated by Kaplan-Meier method.	6 months, 12 months, 18 months, 24 months, 30 months, and 36 months