Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.

Mitral Regurgitation Clinical Trial

— ASCEND  

Official title:

Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04382612
• Other study ID #: 2018-22
• Status: Terminated
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: December 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 1, 2022
• Est. primary completion date: November 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mitral Regurgitation
• Mitral Valve Insufficiency

Intervention

Device:
• HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Repair of the chordae tendinae in the mitral valve.

Locations

Country	Name	City	State
Austria	Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie	Innsbruck	Tirol
Austria	Kepler Universitätsklinikum GmbH	Linz	Oberösterreich
Germany	Kerckhoff Klinik GmbH	Bad Nauheim	Hessen
Germany	Rhön Klinikum Kardiochirurgie	Bad Neustadt	Bayern
Germany	Schüchtermann Klinik	Bad Rothenfelde	Niedersachsen
Germany	Deutsches Herzzentrum Berlin	Berlin
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	Nordrhein-Westfalen
Germany	Universitätsklinik Ulm	Ulm	Baden-Württemberg
Netherlands	St. Antonius Ziekenhuis	Nieuwegein	Utrecht
United Kingdom	Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals	London

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

Austria,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding	Subject's freedom from all-cause mortality, disabling stroke and life-threatening bleeding at 30 days post-implant.	30 days
Primary	Number of Subjects With Procedural Success During the First 30 Days	Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.	30 days