CE Mark Study for the Harpoon Medical Device in Poland

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

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.

Study Overview

• Status: Completed
• Conditions: Mitral Valve Insufficiency; Mitral Valve Prolapse; Mitral Valve Regurgitation
• Intervention / Treatment: Device: Harpoon Medical Device

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Krakow, Poland, 31-202
    • John Paul II University Hospital
  • Warsaw, Poland, 04-628
    • Instytut of Kardiologii & Transplantology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Harpoon Medical TSD-5; This is a prospective, nonrandomized, single-centered European study designed single arm study to demonstrate the performance and safety of the Harpoon Medical TSD-5 in Subjects with degenerative mitral regurgitation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 </=moderate at the conclusion of the procedure and at 30 days post-procedure.	Procedure through 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Piotr Kolsut, MD, PhD, Instytut of Kardiologii & Transplantology; Principal Investigator: Boguslaw Kapelak, MD, PhD, John Paul II University Hospital

Publications and helpful links

General Publications

• Gammie JS, Bartus K, Gackowski A, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Duncan A, Yadav R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pittarello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P, D'Ambra MN. Safety and performance of a novel transventricular beating heart mitral valve repair system: 1-year outcomes. Eur J Cardiothorac Surg. 2021 Jan 4;59(1):199-206. doi: 10.1093/ejcts/ezaa256.
• 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 Implantation Device: Initial Clinical Experience. Circulation. 2016 Jul 19;134(3):189-97. doi: 10.1161/CIRCULATIONAHA.116.022010.
• Goto Y, Funada A, Goto Y. Duration of Prehospital Cardiopulmonary Resuscitation and Favorable Neurological Outcomes for Pediatric Out-of-Hospital Cardiac Arrests: A Nationwide, Population-Based Cohort Study. Circulation. 2016 Dec 20;134(25):2046-2059. doi: 10.1161/CIRCULATIONAHA.116.023821. Epub 2016 Oct 24.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2015
• Primary Completion (Actual): February 8, 2018
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 30, 2015
• First Posted (Estimated): May 4, 2015

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Transapical; Mitral Valve Repair; artificial chordae
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Heart Valve Prolapse; Mitral Valve Insufficiency; Prolapse; Mitral Valve Prolapse
• Other Study ID Numbers: HMFIM -1000-PL-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes