N/A
N=2,035
ABLATOR Ablation Observational Registry
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT02344173 ↗Enrolled (actual)
2,035
Serious AEs
17.5%
Results posted
Jun 2019
Primary outcome: 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 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Aug 2017
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 | — |
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).
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.