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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Oct 2020

Typical duration for not_applicable

Geographic Reach

3 countries

7 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

May 14, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed

5 months until next milestone

Study Start

First participant enrolled

October 2, 2020

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2022

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

January 29, 2024

Completed

Last Updated

January 29, 2024

Status Verified

January 1, 2024

Enrollment Period

2.1 years

First QC Date

May 14, 2020

Results QC Date

December 7, 2023

Last Update Submit

January 9, 2024

Conditions

Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse

Keywords

Mitral valveMid-segment posterior leaflet prolapse of the mitral valveHeart valveChordae tendinaeValve diseaseMitral RegurgitationHarpoonMitral valve repairPosterior leaflet prolapseBeating heart interventionHeart diseaseCardiovascular disease

Outcome Measures

Primary Outcomes (1)

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
1 year post-implant

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

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Edwards Lifescienceslead
ICON plccollaborator

Study Sites (7)

Universitätsklinik Ulm

Ulm, Baden-Wurttemberg, 89070, Germany

Location

Rhön Klinikum Kardiochirurgie

Bad Neustadt an der Saale, Bavaria, 97616, Germany

Location

Klinikum Passau

Passau, Bavaria, 94032, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Lower Saxony, 37075, Germany

Location

Helios Universitätsklinikum Wuppertal

Wuppertal, North Rhine-Westphalia, 42283, Germany

Location

Hospital Son Espases

Palma, Balearic Islands, 07010, Spain

Location

Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Mitral Valve InsufficiencyHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Valve Diseases

Results Point of Contact

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

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 14, 2020

First Posted

May 19, 2020

Study Start

October 2, 2020

Primary Completion

November 17, 2022

Study Completion

November 17, 2022

Last Updated

January 29, 2024

Results First Posted

January 29, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing: Will not share

Locations

ES(1)DE(5)CH(1)

Study Stopped

Observational Registry on the HARPOON Device

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HARPOON™ MVRS

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

HARPOON™ MVRS

Interventions

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (7)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Data Sharing

Locations