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

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

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.

Study Overview

• Status: Terminated
• Conditions: Mitral Regurgitation
• Intervention / Treatment: Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Oberösterreich
    • Linz, Oberösterreich, Austria, 4020
      • Kepler Universitätsklinikum GmbH
  • Tirol
    • Innsbruck, Tirol, Austria, 6020
      • Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Baden-Württemberg
    • Ulm, Baden-Württemberg, Germany, 89070
      • Universitätsklinik Ulm
  • Bayern
    • Bad Neustadt, Bayern, Germany, 97616
      • Rhön Klinikum Kardiochirurgie
  • Hessen
    • Bad Nauheim, Hessen, Germany, 61231
      • Kerckhoff Klinik GmbH
  • Niedersachsen
    • Bad Rothenfelde, Niedersachsen, Germany, 49214
      • Schüchtermann Klinik
  • Nordrhein-Westfalen
    • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Universitätsklinikum Düsseldorf
• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St. Antonius Ziekenhuis
• United Kingdom
  • London, United Kingdom, SW3 6NP
    • Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: HARPOON MVRS; Subjects who were treated with the HARPOON MVRS.	Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS); Repair of the chordae tendinae in the mitral valve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Thomas Walther, Prof Dr med, Goethe University

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2020
• Primary Completion (Actual): November 14, 2022
• Study Completion (Actual): December 1, 2022

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (Actual): May 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Mitral Valve Insufficiency
• Other Study ID Numbers: 2018-22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes