Phase 4
Completed N=60
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
Source: ClinicalTrials.gov NCT01206452 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months — 4; 6 Participants with AF recurrence
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The primary purpose of this study is to assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months |
4; 6 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months |
6; 8 | — |
| SECONDARY Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months |
5; 9 | — |
| SECONDARY Inflammatory Cytokine Response to Ablation Procedure |
11.7; 8.5; 59.6; 63.9; 9.7; 7.5 | — |
| SECONDARY Inflammatory Cytokine Response to Ablation Procedure |
11.7; 8.5; 59.6; 63.9; 9.7; 7.5 | — |
Eligibility Criteria
Inclusion Criteria
- Able to provide written informed consent;
- Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation
Exclusion Criteria
- History of heart failure (right or left or biventricular) or cardiomyopathy.
- Immunosuppressive disorders and systemic fungal infection
- Concurrent use of corticosteroids in one week prior recruitment.
- Allergy or prednisone or its components.
- Other medical conditions were use of corticosteroids is not recommended or contraindicated.
- Patients with chronic and permanent atrial fibrillation.
- Patients with established diagnosis of rheumatological and immunological disorders.
Data sourced from ClinicalTrials.gov (NCT01206452). 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.