N/A
Completed N=721
ACCESS-Europe A Two-Phase Observational Study of the MitraClip® System in Europe
Mitral Valve (MV) Regurgitation
Source: ClinicalTrials.gov NCT01288976 ↗
Enrolled (actual)
721
Serious AEs
62.4%
Results posted
Dec 2017
Primary outcomePrimary: MR Severity — 0.0; 0.0; 0.0; 3.1 percentage of participants
Summary
The MitraClip System enables the European physicians an alternative therapeutic option for patients with mitral regurgitation (MR). Therapeutic alternatives are open-heart cardiac surgery, and palliative medical therapy with or without device therapy. The study will observe the outcomes of patients treated with the MitraClip System throughout 12-months as compared to the outcomes of patients treated by alternative therapies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY MR Severity |
2.8; 27.8; 15.0; 33.3; 9.8; 6.7 | — |
| SECONDARY Procedure Time |
116.9 | — |
| SECONDARY Contrast Volume |
17.0 | — |
| SECONDARY Fluoroscopy Duration |
29.1 | — |
| SECONDARY Number of MitraClip Devices Implanted |
0.4; 60.1; 36.7; 2.6; 0.2 | — |
| SECONDARY ICU and Hospital Stay |
2.5; 7.7 | — |
| SECONDARY Discharge Status and Facility |
2.0; 79.2; 0.4; 17.1; 1.4 | — |
| SECONDARY Discharge MR Severity |
4.4; 46.4; 14.0; 26.3; 4.4; 3.1 | — |
| SECONDARY Kaplan-Meier Freedom From All-Cause Mortality |
81.8 | — |
| SECONDARY Device Embolization and Single Leaflet Device Attachment |
0; 27 | — |
| SECONDARY 1-Day Post-Procedure Safety Outcomes |
0; 0; 0.2; 0; 1.1; 0.9 | — |
| SECONDARY Need for Mitral Valve Surgery |
6.3 | — |
| SECONDARY NYHA Functional Class |
25.1; 46.4; 26.8; 1.7 | — |
| SECONDARY The Change in 6 Minute Walk Test Distance From Baseline to 12 Months |
274.7; 334.2; 59.5 | — |
| SECONDARY Change in Minnesota Living With Heart Failure (MLWHF) Quality of Life Score From Baseline to 12 Months |
41.6; 28.1; -13.5 | — |
| SECONDARY Six Minute Walk Test Distance (6MWT) |
334.2 | — |
Eligibility Criteria
Inclusion Criteria
- Per the current approved labeling for the Conformity European (CE) Marked MitraClip System.
Exclusion Criteria
- Per the current approved labeling for the CE Marked MitraClip System.
Data sourced from ClinicalTrials.gov (NCT01288976). 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.