Mitral RegurgitationASCENDNCT04382612
Treatment of Mitral Regurgitation Using a Minimally Invasive Approach With the HARPOON Device.
A study testing HARPOON Beating Heart Mitral Valve Repair System (MVRS) in people with Mitral Regurgitation, run by Edwards Lifesciences at 10 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- 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
- 42 participants
- Where
- 10 sitesin 4 countries
- Study dates
- 2 Oct 2020to 1 Dec 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
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
Germany6 sites
Kerckhoff Klinik GmbH
Bad Nauheim, Hesse, 61231
Rhön Klinikum Kardiochirurgie
Bad Neustadt an der Saale, Bavaria, 97616
Schüchtermann Klinik
Bad Rothenfelde, Lower Saxony, 49214
Deutsches Herzzentrum Berlin
Berlin, 13353
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Universitätsklinik Ulm
Ulm, Baden-Wurttemberg, 89070
Austria2 sites
Medizinische Universität Innsbruck, Universitätsklinik für Herzchirurgie
Innsbruck, Tyrol, 6020
Kepler Universitätsklinikum GmbH
Linz, Upper Austria, 4020
United Kingdom1 site
Guy's and St Thomas' NHS FOUNDATION TRUST, of Royal Brompton and Harefield Hospitals
London, SW3 6NP
About this study
Official title: Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
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.
Read the 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.
- Conditions
- Mitral Regurgitation
- Being tested
- HARPOON Beating Heart Mitral Valve Repair System (MVRS)
- Medical subject headings
- Mitral Valve Insufficiency
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 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.
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.
Measured: 30 days
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 (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start2 Oct 2020
- Primary completion14 Nov 2022
- Study completion1 Dec 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 Mitral RegurgitationStudies 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
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Walther, Prof Dr med, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382612
- Sponsor's protocol ID
- 2018-22
- Acronym
- ASCEND
- Status last verified
- Dec 2023
- First submitted
- 6 May 2020
- Last updated
- 22 Dec 2023
- 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 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Performance of the HARPOON™ Beating Heart Mitral Valve Repair System; a Multi-center Post-market Study (ASCEND)
- ClinicalTrials.gov ID
- NCT04382612
- Acronym / sponsor ID
- ASCEND / 2018-22
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2020 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 11 May 2020 (actual)
- Results
- Posted 22 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| 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 (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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
Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding
Time frame: 30 days
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
Time frame: 30 days
Subject's procedural success at 30 days post-treatment, as measured by: Technical success (defined as implantation of at least three chords, leaving the operating room and no conversion to open heart surgery) with reduction of MR to less than or equal to mild and the absence of major device or procedure-related SAEs.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- 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.
Related trials for Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
LEFT ATRIAL MONITORING IN PATIENTS BEFORE AND AFTER MITRAL SURGERY - LAMBDA STUDY
Mitral Regurgitation, Mitral Valve Disease
Not yet recruitingObservational study
Multi-center Study of Three-Dimensional Transesophageal Echocardiography in Patients With Secondary Mitral Regurgitation
Mitral Valve Insufficiency
Recruiting
Mitral Valve Edge-to-Edge Repair in Patients With Exercise-Induced Severe Mitral Regurgitation
Heart Failure - NYHA II - IV, Mitral Regurgitation Functional
Not yet recruiting
Early Feasibility Study of the Capstan Medical TMVR System
Mitral Regurgitation (MR)
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
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HARPOON Beating Heart Mitral Valve Repair System (MVRS) in people with Mitral Regurgitation, run by Edwards Lifesciences at 10 sites in 4 countries.
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 5 inclusion and 11 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 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Austria, Netherlands, United Kingdom. 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 22 Dec 2023). 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?
Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Dec 2023.