N/A
Completed N=129
Utilizing Novel Dipole Density Capabilities to Objectively Visualize the Etiology of Rhythms in Atrial Fibrillation
Source: ClinicalTrials.gov NCT02825992 ↗Enrolled (actual)
129
Serious AEs
25.6%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) — 3; 126 Participants
Summary
A prospective, single-arm, multi-center, multi-national, non-randomized, post-market study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-002 - EU)
A prospective, single-arm, multi-center, multi-national non-randomized study designed to provide clinical data regarding the use of the AcQMap™ System in the ablation of persistent atrial fibrillation. (CL-AF-001 - Canadian)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Freedom From Device/Procedure Related Major Adverse Events (MAEs) |
3; 126 | — |
| SECONDARY Number of Participants Who Experienced at Least One Adverse Events. |
1; 1; 21; 1; 3; 1 | — |
| SECONDARY Number of Participants Who Were in Sinus Rhythm Following the Ablation Procedure. |
125 | — |
| SECONDARY Number of Participants Who Were AF Free at, 6, 9, and 12 Months Post Ablation. |
79; 49; 65; 36; 84; 52 | — |
Eligibility Criteria
Inclusion Criteria
- Scheduled for an ablation of persistent atrial fibrillation
Exclusion Criteria
- Any duration of continuous AF lasting longer than 12 months
- Previous AF ablation
- Significant structural heart disease
- Previous cerebral infarct
- Major bleeding disorders
- Pregnant or lactating
Data sourced from ClinicalTrials.gov (NCT02825992). 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.