N/A
Completed N=1,041
The MitraClip® EXPAND Study of the Next Generation of MitraClip® Devices
Mitral Valve Regurgitation · Mitral Regurgitation
Source: ClinicalTrials.gov NCT03502811 ↗
Enrolled (actual)
1,041
Serious AEs
37.7%
Results posted
Feb 2022
Primary outcomePrimary: Safety Measure: Number of Participants With Major Adverse Events (MAE) — 24; 0; 8; 11 Participants
Summary
The MitraClip EXPAND Study (A Contemporary, Prospective Study Evaluating Real-world Experience of Performance and Safety for the Next Generation of MitraClip Devices) is designed to confirm the safety and performance of the MitraClip NTR System and MitraClip XTR System.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Measure: Number of Participants With Major Adverse Events (MAE) |
24; 0; 8; 11 | — |
| PRIMARY Performance Measure: Number of Participants With Mitral Regurgitation (MR) Reduction to ≤2+ |
845 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who give consent for their participation
- Subjects scheduled to receive the MitraClip per the current approved indications for use
- Subjects with Symptomatic MR (≥3+)
Exclusion Criteria
- Subjects participating in another clinical study that may impact the follow-up or results of this study
Data sourced from ClinicalTrials.gov (NCT03502811). 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. Informational only — not medical advice.