Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet ProlapseREPLICATENCT04393779

Observational Registry on the HARPOON Device

A study testing HARPOON Beating Heart Mitral Valve Repair System (MVRS) in people with Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse, run by Edwards Lifesciences at 7 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
What is being tested?: HARPOON Beating Heart Mitral Valve Repair System (MVRS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 7 sitesin 3 countries
Study dates: 2 Oct 2020to 17 Nov 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Trial locations and contacts

7 sites in 3 countries.

Country

City, postcode or hospital

7 sites in 3 countries

Germany5 sites

Rhön Klinikum Kardiochirurgie
Bad Neustadt an der Saale, Bavaria, 97616
Universitätsmedizin Göttingen
Göttingen, Lower Saxony, 37075
Klinikum Passau
Passau, Bavaria, 94032
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, 89070
Helios Universitätsklinikum Wuppertal
Wuppertal, North Rhine-Westphalia, 42283

Other trials in Germany

Spain1 site

Hospital Son Espases
Palma, Balearic Islands, 07010

Other trials in Spain

Switzerland1 site

Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern
Bern, 3010

Other trials in Switzerland

About this study

Official title: Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry

To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.

Read the detailed description

This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.

Conditions: Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Being tested: HARPOON Beating Heart Mitral Valve Repair System (MVRS)
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
Medical subject headings: Mitral Valve Insufficiency, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HARPOON Beating Heart Mitral Valve Repair System (MVRS)Device
Repair of the chordae tendinae in the mitral valve.

Study groups in NCT04393779
Study group	Role	What they receive
HARPOON™ MVRS	Other	Subjects who were treated with the HARPOON MVRS. Receives: Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 1 year post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 202017 Nov 2022

First posted19 May 2020
Study start2 Oct 2020
Primary completion17 Nov 2022
Study completion17 Nov 2022

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet ProlapseStudies of the same condition, open and under way.
More trials run by Edwards LifesciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Single arm study
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04393779
Sponsor's protocol ID: 2019-12
Acronym: REPLICATE
Status last verified: Jan 2024
First submitted: 14 May 2020
Last updated: 29 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: Individual participant data will not be available to other researchers.

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Beating Heart Mitral Valve REPair With the HARPOON™ System: ReaL World Outcomes From a multICenter observATional European Registry
ClinicalTrials.gov ID: NCT04393779
Acronym / sponsor ID: REPLICATE / 2019-12
Conditions: 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
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 26 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Collaborators: ICON plc
Study start: 2 Oct 2020 (actual)
Primary completion: 17 Nov 2022 (actual)
Study completion: 17 Nov 2022 (actual)
First posted: 19 May 2020 (actual)
Results: Posted 29 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Single arm study

Arm	Type	Receives
HARPOON™ MVRS	Other	Device: HARPOON Beating Heart Mitral Valve Repair System (MVRS)Subjects who were treated with the HARPOON MVRS.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HARPOON Beating Heart Mitral Valve Repair System (MVRS)Repair of the chordae tendinae in the mitral valve.	Device	HARPOON™ MVRS

Primary outcome

Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant
Time frame: 1 year post-implant
Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant

Results and safety

Results posted to the registry on 29 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HARPOON™ MVRS	26	21

Primary outcome: Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant

Time frame: 1 year post-implant. Number. Unit: Percent of participants

Measure	HARPOON™ MVRS n = 15
Value	81.0

Population analysed: This outcome is reported as a Kaplan Meier estimate for subjects who were attempted to be treated in the trial where data is available. The number of participants analyzed at the 1-year timepoint is equivalent to the number of patients at risk at that timepoint.

Adverse events

Time frame: Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HARPOON™ MVRS	6 of 26 (23.1%)	2 of 26 (7.7%)	1 of 26

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Walther, Prof Dr med principal investigator

Goethe University

7 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant (time frame: 1 year post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04393779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.