Cardiovascular Diseases, Heart Diseases, Heart Valve Diseases, Mitral Valve Insufficiency
Conditions
Keywords
NeoChord, DS1000, Mitral Valve, Mitral Valve Regurgitation, MR, Mitral Valve Repair, Mitral Valve Prolapse, Artificial Chordae
Brief summary
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
Interventions
None listed
Sponsors
NeoChord
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Grade 3+ or 4+ mitral valve regurgitation
Exclusion criteria
* Heavily calcified valves * Valvular retraction with severely reduced mobility * Active bacterial endocarditis * Complex mechanism of MR (leaflet perforation, etc.) * Significant tethering of leaflets * Inflammatory valve disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day. | To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure |
Countries
France, Germany, Italy, Lithuania, Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall All subjects | 126 |
| Total | 126 |
Baseline characteristics
| Characteristic | Overall | — |
|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 91 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 126 |
| other Total, other adverse events | 9 / 126 |
| serious Total, serious adverse events | 37 / 126 |
Outcome results
Primary
Procedure Success
To describe the rate of subjects with at least one neochord placed using the DS1000 System AND a reduction in mitral regurgitation ≤ 2+ at the time of the procedure
Time frame: The patient will be evaluated from the procedure through the hospital discharge. Approximately 1 day.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall | Procedure Success | >1 neochord placed and MR</= 2+ | 121 Participants |
| Overall | Procedure Success | No neochords placed or MR>/=3+ | 5 Participants |