N/A
Completed N=2,035
ABLATOR Ablation Observational Registry
Source: ClinicalTrials.gov NCT02344173 ↗Enrolled (actual)
2,035
Serious AEs
17.5%
Results posted
Jun 2019
Primary outcomePrimary: Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. — 1297 Participants
Summary
The purpose of this registry is to assess the performance and clinical effectiveness of a combination of SJM mapping and ablation products in the treatment of subjects with atrial fibrillation (AF).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects That Achieved Freedom From AF/AFL/AT (Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia) With or Without the Use of Anti-arrhythmic Drugs After a 3-month Blanking Period. |
1297 | — |
| PRIMARY Number of Subjects That Experienced 1 or More Procedure and/or Device-related Cardiovascular SAE/SADEs. |
43 | — |
Eligibility Criteria
Inclusion Criteria
All patients who are indicated for an atrial fibrillation ablation procedure.
Exclusion Criteria
Pregnant women.
Data sourced from ClinicalTrials.gov (NCT02344173). 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.