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

NCT04382612 | Terminated Results FDA Device

• 1 other identifier: 2018-22
• Study Type: interventional
• Target: 42
• Locations: 4 countries
• Sites: 10

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.

Conditions

Mitral Regurgitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

HARPOON MVRS

OTHER

Subjects who were treated with the HARPOON MVRS.

Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Interventions

HARPOON Beating Heart Mitral Valve Repair System (MVRS) DEVICE

Repair of the chordae tendinae in the mitral valve.

HARPOON MVRS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (10)

Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie

Innsbruck, Tyrol, 6020, Austria

Location

Kepler Universitätsklinikum GmbH

Linz, Upper Austria, 4020, Austria

Location

Universitätsklinik Ulm

Ulm, Baden-Wurttemberg, 89070, Germany

Location

Rhön Klinikum Kardiochirurgie

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Kerckhoff Klinik GmbH

Bad Nauheim, Hesse, 61231, Germany

Location

Schüchtermann Klinik

Bad Rothenfelde, Lower Saxony, 49214, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

Location

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals

London, SW3 6NP, United Kingdom

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Sabrina Hundt, Director of Clinical Affairs, Surgical Structural Heart
• Organization: Edwards Lifesciences, LLC

Sabrina_Hundt@edwards.com

949-250-2500

Study Officials

• Thomas Walther, Prof Dr med

  Goethe University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: October 2, 2020
• Primary Completion: November 14, 2022
• Study Completion: December 1, 2022
• Last Updated: December 22, 2023
• Results First Posted: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1); AU (2); GB (1); DE (6)