Clinical trial NCT02768870: CE Mark Study for the Harpoon Medical Device
Official title: Mitral TRans-Apical neoChordal Echo-guided Repair (TRACER) Trial
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: 2016-05-11
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 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 TOE-guided chordal length adjustment and 8) less complicated procedure that is teachable and adoptable.

Detailed 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.

Eligibility criteria: 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 chordae tendineae implantation coaptation surface is adequate in the judgment of the operating surgeon and the patient eligibility committee
* Degenerative mitral valve disease
* 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
* Anterior or bileaflet prolapse
* Functional MR
* 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 Transoesophageal 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: End of procedure through 30 days
measure: Percentage of Subject's With Freedom From Serious Adverse Events (SAE) </= 30 Days
timeFrame: Procedure and 30 days
measure: Subject's Serious Adverse Events (SAE) Through Discharge
timeFrame: Discharge, an average of 5 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: Milan
country: Italy
facility: Ospedale San Raffaele Hospital
city: Padova
country: Italy
facility: University Hospital Padova
city: London
country: United Kingdom
facility: The Royal Brompton and Harefield NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Trust
Study officials:
affiliation: University Hospital Padova
name: Gino Gerosa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: OSR San Raffaele Hospital
name: Ottavio Alfieri, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Brompton Hospital
name: Alison Duncan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gammie JS, Bartus K, Gackowski A, D'Ambra MN, Szymanski P, Bilewska A, Kusmierczyk M, Kapelak B, Rzucidlo-Resil J, Moat N, Duncan A, Yadev R, Livesey S, Diprose P, Gerosa G, D'Onofrio A, Pitterello D, Denti P, La Canna G, De Bonis M, Alfieri O, Hung J, Kolsut P. Beating-Heart Mitral Valve Repair Using a Novel ePTFE Cordal Implantation Device: A Prospective Trial. J Am Coll Cardiol. 2018 Jan 2;71(1):25-36. doi: 10.1016/j.jacc.2017.10.062. Epub 2017 Nov 1.
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.