Clinical trial NCT02432196: CE Mark Study for the Harpoon Medical Device in Poland
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mitral Valve Regurgitation
Mitral Valve Prolapse
Mitral Valve Insufficiency
Keywords: Mitral Valve Repair
Transapical
artificial chordae
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2015-05-04
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Subject's Procedural Success During the First 30 Days
timeFrame: Procedure through 30 days
measure: Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
timeFrame: Procedure through 30 days
measure: Subject's Serious Adverse Events (SAE) Through Discharge
timeFrame: Discharge, an average of 6 days post implant
Secondary outcomes:
measure: Subject's Severity of Mitral Regurgitation Over Time
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
measure: Percentage of Subject's With Freedom From Serious Adverse Events (SAE) Post-implant > 30 Days
timeFrame: 6 months, 12 months, 18 months, 24 months, 30 months, and 36 months
Other outcomes:
Locations:
city: Krakow
country: Poland
facility: John Paul II University Hospital
city: Warsaw
country: Poland
facility: Instytut of Kardiologii & Transplantology
Study officials:
affiliation: John Paul II University Hospital
name: Boguslaw Kapelak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Instytut of Kardiologii & Transplantology
name: Piotr Kolsut, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.