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

Primary Purpose

Mitral Regurgitation

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Regurgitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kepler Universitätsklinikum GmbH
  • Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
  • Universitätsklinik Ulm
  • Rhön Klinikum Kardiochirurgie
  • Kerckhoff Klinik GmbH
  • Schüchtermann Klinik
  • Universitätsklinikum Düsseldorf
  • Deutsches Herzzentrum Berlin
  • St. Antonius Ziekenhuis
  • Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HARPOON MVRS

Arm Description

Subjects who were treated with the HARPOON MVRS.

Outcomes

Primary Outcome Measures

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.
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 with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2020
Last Updated
January 23, 2023
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT04382612
Brief Title
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
November 14, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Regurgitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HARPOON MVRS
Arm Type
Other
Arm Description
Subjects who were treated with the HARPOON MVRS.
Intervention Type
Device
Intervention Name(s)
HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Intervention Description
Repair of the chordae tendinae in the mitral valve.
Primary Outcome Measure Information:
Title
Percentage of Subject's With Freedom from all-cause mortality, disabling stroke and life-threatening bleeding
Description
Subject's freedom from all-cause mortality, disabling stroke and life- threatening bleeding at 30 days post-implant.
Time Frame
30 days
Title
Number of Subjects With Procedural Success During the First 30 Days
Description
Subject's procedural success at 30 days post-treatment, as measured by: Technical success with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Walther, Prof Dr med
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Payam Akhyari, Prof Dr med
Organizational Affiliation
Heine University Dusseldorf
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kepler Universitätsklinikum GmbH
City
Linz
State/Province
Oberösterreich
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
City
Innsbruck
State/Province
Tirol
ZIP/Postal Code
6020
Country
Austria
Facility Name
Universitätsklinik Ulm
City
Ulm
State/Province
Baden-Württemberg
ZIP/Postal Code
89070
Country
Germany
Facility Name
Rhön Klinikum Kardiochirurgie
City
Bad Neustadt
State/Province
Bayern
ZIP/Postal Code
97616
Country
Germany
Facility Name
Kerckhoff Klinik GmbH
City
Bad Nauheim
State/Province
Hessen
ZIP/Postal Code
61231
Country
Germany
Facility Name
Schüchtermann Klinik
City
Bad Rothenfelde
State/Province
Niedersachsen
ZIP/Postal Code
49214
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf
City
Düsseldorf
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
40225
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be available to other researchers.

Learn more about this trial

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

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