N/A
N=126
NeoChord TACT Post-Market Surveillance Registry
Mitral Valve Insufficiency · Heart Valve Diseases · Heart Diseases · Cardiovascular Diseases
Bottom Line
View on ClinicalTrials.gov: NCT01784055 ↗Enrolled (actual)
126
Serious AEs
29.4%
Results posted
Apr 2018
Primary outcome: Primary: Procedure Success — 121; 5 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- NeoChord
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Procedure Success |
121; 5 | — |
Summary
To monitor the long-term performance of the CE Marked NeoChord Artificial Chordae Delivery System
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01784055). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.