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Low enrollment
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| Name | Class |
|---|---|
| ICON plc | INDUSTRY |
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To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse.
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HARPOON™ MVRS | Other | Subjects who were treated with the HARPOON MVRS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HARPOON Beating Heart Mitral Valve Repair System (MVRS) | Device | Repair of the chordae tendinae in the mitral valve. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Walther, Prof Dr med | Goethe University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik Ulm | Ulm | Baden-Wurttemberg | 89070 | Germany | ||
| Rhön Klinikum Kardiochirurgie |
Individual participant data will not be available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | HARPOON™ MVRS | Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HARPOON™ MVRS | Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Number | Percent of participants | 1 year post-implant |
|
Adverse events occurring from baseline through 25 months post implant of the enrolled cohort.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HARPOON™ MVRS | Subjects who were treated with the HARPOON MVRS. HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ACCESS SITE AND VASCULAR COMPLICATIONS - DAMAGE TO THE NATIVE MITRAL VALVE APPARATUS - CHORD | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| REGURGITATION - RECURRENT MITRAL MODERATE | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sabrina Hundt, Director of Clinical Affairs, Surgical Structural Heart | Edwards Lifesciences, LLC | 949-250-2500 | Sabrina_Hundt@edwards.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2020 | Dec 6, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008944 | Mitral Valve Insufficiency |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
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Single arm study
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| Bad Neustadt an der Saale |
| Bavaria |
| 97616 |
| Germany |
| Klinikum Passau | Passau | Bavaria | 94032 | Germany |
| Universitätsmedizin Göttingen | Göttingen | Lower Saxony | 37075 | Germany |
| Helios Universitätsklinikum Wuppertal | Wuppertal | North Rhine-Westphalia | 42283 | Germany |
| Hospital Son Espases | Palma | Balearic Islands | 07010 | Spain |
| Insel Gruppe AG, Universitätsklinik für Kardiologie, Schweizer Herz- und Gefässzentrum Bern | Bern | 3010 | Switzerland |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 1 |
| 26 |
| 6 |
| 26 |
| 2 |
| 26 |
| BLOOD SEPSIS | Blood and lymphatic system disorders | Systematic Assessment |
|
| REGURGITATION - RECURRENT MITRAL SEVERE | Cardiac disorders | Systematic Assessment |
|
| DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT PROBLEMS | Product Issues | Systematic Assessment |
|
| DEVICE SPECIFIC COMPLICATION - OTHER CHORD/KNOT PROBLEMS | Product Issues | Systematic Assessment |
|
PI can't publish/present on overall study results not yet published but may publish his own data subject to EW review prior to submission/presentation to ensure proprietary information shall not be divulged. Publication/presentation of the PI's site-specific results of devices which haven't been market released and which still may be undergoing development, shall not include claims of device safety/effectiveness and will require the review/approval of EW.