Clinical trial NCT04382612: Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
Official title: Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-05-11
Enrollment: 42
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: To evaluate the long-term safety and performance of the HARPOON™ MVRS for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

Detailed description: This trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.

Eligibility criteria: Inclusion Criteria:

1. Subject is \> 18 years old
2. Presence of severe MR as read on a transthoracic echocardiographic study
3. Mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient eligibility committee and the operating surgeon
4. Degenerative mitral valve disease with mid-segment P2 prolapse
5. 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

Exclusion Criteria:

1. Patient is of the age where further growth is expected
2. Active endocarditis
3. Left ventricular or left atrial appendage thrombus
4. Severe mitral annular and/or leaflet calcification
5. Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
6. Mitral stenosis
7. Functional Mitral Valve disease
8. Previous mitral valve replacement surgery
9. Fragile or thinning apex
10. Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
11. Patient is pregnant or lactating

Primary outcomes:
measure: Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding
timeFrame: 30 days
measure: Number of Subjects With Procedural Success During the First 30 Days
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH
state: Oberösterreich
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
state: Tirol
city: Ulm
country: Germany
facility: Universitätsklinik Ulm
state: Baden-Württemberg
city: Bad Neustadt
country: Germany
facility: Rhön Klinikum Kardiochirurgie
state: Bayern
city: Bad Nauheim
country: Germany
facility: Kerckhoff Klinik GmbH
state: Hessen
city: Bad Rothenfelde
country: Germany
facility: Schüchtermann Klinik
state: Niedersachsen
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals
Study officials:
affiliation: Goethe University
name: Thomas Walther, Prof Dr med
role: PRINCIPAL_INVESTIGATOR
References: