Status:
TERMINATED
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
Lead Sponsor:
Edwards Lifesciences
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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
- Subject is \> 18 years old
- Presence of severe MR as read on a transthoracic echocardiographic study
- 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
- Degenerative mitral valve disease with mid-segment P2 prolapse
- 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
- Patient is of the age where further growth is expected
- Active endocarditis
- Left ventricular or left atrial appendage thrombus
- Severe mitral annular and/or leaflet calcification
- Cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen
- Mitral stenosis
- Functional Mitral Valve disease
- Previous mitral valve replacement surgery
- Fragile or thinning apex
- Contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum)
- Patient is pregnant or lactating
Key Trial Info
Start Date :
October 2 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT04382612
Start Date
October 2 2020
End Date
December 1 2022
Last Update
December 22 2023
Active Locations (10)
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1
Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
Innsbruck, Tyrol, Austria, 6020
2
Kepler Universitätsklinikum GmbH
Linz, Upper Austria, Austria, 4020
3
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, Germany, 89070
4
Rhön Klinikum Kardiochirurgie
Bad Neustadt an der Saale, Bavaria, Germany, 97616