CE Mark Study for the Harpoon Medical Device in Poland

NCT02432196 | Completed Results FDA Device

• 1 other identifier: HMFIM -1000-PL-04
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mitral Valve Regurgitation; Mitral Valve Prolapse; Mitral Valve Insufficiency

Keywords

Mitral Valve Repair; Transapical; artificial chordae

Outcome Measures

Primary Outcomes (3)

• 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

• 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 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 Outcomes (2)

• Subject's Severity of Mitral Regurgitation Over Time

  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

  6 months, 12 months, 18 months, 24 months, 30 months, and 36 months

Study Arms (1)

Harpoon Medical TSD-5

EXPERIMENTAL

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

Interventions

Harpoon Medical Device 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.

Harpoon Medical TSD-5

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (2)

John Paul II University Hospital

Krakow, 31-202, Poland

Location

Instytut of Kardiologii & Transplantology

Warsaw, 04-628, Poland

Location

Related Publications (3)

• 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.

  PMID: 27436878 RESULT

• 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.

  PMID: 33038223 DERIVED

• 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.

  PMID: 27777278 DERIVED

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: Sabrina Hundt, Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Sabrina_Hundt@edwards.com

949-250-2500

Study Officials

• Boguslaw Kapelak, MD, PhD

  John Paul II University Hospital

  PRINCIPAL INVESTIGATOR

• Piotr Kolsut, MD, PhD

  Instytut of Kardiologii & Transplantology

  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

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 4, 2015
• Study Start: December 11, 2015
• Primary Completion: February 8, 2018
• Study Completion: November 16, 2022
• Last Updated: January 22, 2024
• Results First Posted: November 25, 2019

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (2)