Back to resultsObservational Registry on the HARPOON Device (REPLICATE)
Primary Purpose
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Sponsored by
About this trial
This is an interventional treatment trial for Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse focused on measuring Mitral valve, Mid-segment posterior leaflet prolapse of the mitral valve, Heart valve, Chordae tendinae, Valve disease, Mitral Regurgitation, Harpoon, Mitral valve repair, Posterior leaflet prolapse, Beating heart intervention, Heart disease, Cardiovascular disease
Eligibility Criteria
Inclusion Criteria:
- Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.
Exclusion Criteria:
- N/A
Sites / Locations
- Universitätsklinik Ulm
- Rhön Klinikum Kardiochirurgie
- Klinikum Passau
- Universitätsmedizin Göttingen
- Helios Universitätsklinikum Wuppertal
- Hospital Son Espases
- Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern
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
Freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
Secondary Outcome Measures
Full Information
NCT ID
NCT04393779
First Posted
May 14, 2020
Last Updated
March 13, 2023
Sponsor
Edwards Lifesciences
Collaborators
ICON plc
1. Study Identification
Unique Protocol Identification Number
NCT04393779
Brief Title
Observational Registry on the HARPOON Device
Acronym
REPLICATE
Official Title
Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
October 2, 2020 (Actual)
Primary Completion Date
November 17, 2022 (Actual)
Study Completion Date
November 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences
Collaborators
ICON plc
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 collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
Detailed Description
This is a single arm, prospective, multicenter, post-market, observational registry 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
Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Keywords
Mitral valve, Mid-segment posterior leaflet prolapse of the mitral valve, Heart valve, Chordae tendinae, Valve disease, Mitral Regurgitation, Harpoon, Mitral valve repair, Posterior leaflet prolapse, Beating heart intervention, Heart disease, Cardiovascular disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm study
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (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
Freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
Description
Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant
Time Frame
1 year post-implant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.
Exclusion Criteria:
N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Walther, Prof Dr med
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
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
Klinikum Passau
City
Passau
State/Province
Bayern
ZIP/Postal Code
94032
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
State/Province
Niedersachsen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Helios Universitätsklinikum Wuppertal
City
Wuppertal
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42283
Country
Germany
Facility Name
Hospital Son Espases
City
Palma
State/Province
Illes Balears
ZIP/Postal Code
07010
Country
Spain
Facility Name
Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
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
Observational Registry on the HARPOON Device
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