Mitral Regurgitation
Conditions
Brief 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.
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.
Interventions
Repair of the chordae tendinae in the mitral valve.
Sponsors
Edwards Lifesciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding | 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 | 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. |
Countries
Austria, Germany, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HARPOON MVRS The attempt to treat cohort with the HARPOON MVRS.
HARPOON Beating Heart Mitral Valve Repair System (MVRS): Repair of the chordae tendinae in the mitral valve. | 41 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen failure - no attempt to use the device | 1 |
Baseline characteristics
| Characteristic | HARPOON MVRS | — |
|---|---|---|
| Age, Continuous | 67.2 Years STANDARD_DEVIATION 11.75 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 34 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 42 |
| other Total, other adverse events | 20 / 42 |
| serious Total, serious adverse events | 15 / 42 |
Outcome results
Primary
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.
Time frame: 30 days
Population: Subjects who completed a 30-day follow-up. The outcome is reported for subjects where data is available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HARPOON MVRS | Number of Subjects With Procedural Success During the First 30 Days | 26 Participants |
Primary
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.
Time frame: 30 days
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 30-day timepoint is equivalent to the number of patients at risk at that timepoint.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| HARPOON MVRS | Percentage of Subject's With Freedom From All-cause Mortality, Disabling Stroke and Life-threatening Bleeding | 97.6 percentage of subjects |