Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse
Conditions
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
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.
Detailed description
This is a single arm, prospective, multicenter, post-market, observational registry that will evaluate subjects for up to 5 years post treatment.
Interventions
Repair of the chordae tendinae in the mitral valve.
Sponsors
ICON plc
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* N/A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant | 1 year post-implant | Subject's freedom from re-operation due to recurrent severe mitral regurgitation through 1-year post-implant |
Countries
Germany, Spain, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Device reintervention or explant | 4 |
Baseline characteristics
| Characteristic | HARPOON™ MVRS | — |
|---|---|---|
| Age, Continuous | 65.7 Years STANDARD_DEVIATION 10.87 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 4 Participants | — |
| Sex: Female, Male Male | 22 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 2 / 26 |
| serious Total, serious adverse events | 6 / 26 |
Outcome results
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
Time frame: 1 year post-implant
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HARPOON™ MVRS | Freedom From Re-operation Due to Recurrent Severe Mitral Regurgitation Through 1-year Post-implant | 81.0 Percent of participants |