MedDataX Logo

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

NCT ID: NCT04382612

Last Updated: 2023-12-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-02

Study Completion Date

2022-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Regurgitation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HARPOON MVRS

Subjects who were treated with the HARPOON MVRS.

Group Type OTHER

HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Intervention Type DEVICE

Repair of the chordae tendinae in the mitral valve.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

HARPOON Beating Heart Mitral Valve Repair System (MVRS)

Repair of the chordae tendinae in the mitral valve.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thomas Walther, Prof Dr med

Role: PRINCIPAL_INVESTIGATOR

Goethe University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie

Innsbruck, Tyrol, Austria

Site Status

Kepler Universitätsklinikum GmbH

Linz, Upper Austria, Austria

Site Status

Universitätsklinik Ulm

Ulm, Baden-Wurttemberg, Germany

Site Status

Rhön Klinikum Kardiochirurgie

Bad Neustadt an der Saale, Bavaria, Germany

Site Status

Kerckhoff Klinik GmbH

Bad Nauheim, Hesse, Germany

Site Status

Schüchtermann Klinik

Bad Rothenfelde, Lower Saxony, Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Deutsches Herzzentrum Berlin

Berlin, , Germany

Site Status

St. Antonius Ziekenhuis

Nieuwegein, Utrecht, Netherlands

Site Status

Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy Austria Germany Netherlands United Kingdom

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2018-22

Identifier Type: -

Identifier Source: org_study_id