Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation; Ablation
Brief 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.
Detailed description
The purpose of this study is: 1. To assess the efficacy of oral prednisone in improving the outcomes of pulmonary vein isolation with radiofrequency ablation. 2. To measure the inflammatory cytokine (TNF-α, IL-1, IL-6, IL-8) response to radiofrequency ablation for atrial fibrillation with or without prior prednisone treatment.
Interventions
DRUGPrednisone
60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
OTHERPlacebo
60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
PROCEDUREAblation Procedure
Atrial Fibrillation (AF) ablation
Sponsors
Dhanunjaya Lakkireddy, MD, FACC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Able to provide written informed consent; 2. Scheduled for radiofrequency ablation procedure for treatment of atrial fibrillation
Exclusion criteria
1. History of heart failure (right or left or biventricular) or cardiomyopathy. 2. Immunosuppressive disorders and systemic fungal infection 3. Concurrent use of corticosteroids in one week prior recruitment. 4. Allergy or prednisone or its components. 5. Other medical conditions were use of corticosteroids is not recommended or contraindicated. 6. Patients with chronic and permanent atrial fibrillation. 7. Patients with established diagnosis of rheumatological and immunological disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months | From 6 months up to 12 months post-procedure | Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months | From 0 months up to 3 months post procedure | Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. |
| Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months | From 3 months up to 6 months post-procedure | Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence. |
| Inflammatory Cytokine Response to Ablation Procedure | Immediately Post-Ablation Procedure | Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ablation Plus Placebo Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation | 30 |
| Ablation Plus Prednisone Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Total | Ablation Plus Prednisone | Ablation Plus Placebo |
|---|---|---|---|
| AF Duration | 6.45 years STANDARD_DEVIATION 6.45 | 4.98 years STANDARD_DEVIATION 4.81 | 7.92 years STANDARD_DEVIATION 7.66 |
| Age, Continuous | 63.12 years STANDARD_DEVIATION 8.75 | 63 years STANDARD_DEVIATION 8.69 | 63.23 years STANDARD_DEVIATION 8.95 |
| Body Mass Index (BMI) | 29.51 kg/m^2 STANDARD_DEVIATION 5.63 | 30.53 kg/m^2 STANDARD_DEVIATION 5.93 | 28.48 kg/m^2 STANDARD_DEVIATION 5.19 |
| Sex: Female, Male Female | 14 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Male | 46 Participants | 24 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 30 | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Time frame: From 6 months up to 12 months post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation Plus Placebo | Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months | 4 Participants with AF recurrence |
| Ablation Plus Prednisone | Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months | 6 Participants with AF recurrence |
Secondary
Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.
Time frame: Immediately Post-Ablation Procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-1 level | 11 pg/ml | Standard Deviation 2.8 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-8 level | 15.3 pg/ml | Standard Deviation 8.14 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | TNF-α level | 7.9 pg/ml | Standard Deviation 3.2 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-6 level | 15.78 pg/ml | Standard Deviation 13.19 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-6 level | 9.03 pg/ml | Standard Deviation 7.026 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-1 level | 7.94 pg/ml | Standard Deviation 2.1 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | TNF-α level | 5.45 pg/ml | Standard Deviation 2.6 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-8 level | 10.54 pg/ml | Standard Deviation 9.63 |
Secondary
Inflammatory Cytokine Response to Ablation Procedure
Measure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.
Time frame: 24 Hours after Ablation Procedure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-1 level | 11.7 pg/ml | Standard Deviation 15.4 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-8 level | 59.6 pg/ml | Standard Deviation 54.9 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | TNF-α level | 9.7 pg/ml | Standard Deviation 15.8 |
| Ablation Plus Placebo | Inflammatory Cytokine Response to Ablation Procedure | IL-6 level | 40.9 pg/ml | Standard Deviation 39.9 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-6 level | 40.2 pg/ml | Standard Deviation 49.7 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-1 level | 8.5 pg/ml | Standard Deviation 12.1 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | TNF-α level | 7.5 pg/ml | Standard Deviation 16.1 |
| Ablation Plus Prednisone | Inflammatory Cytokine Response to Ablation Procedure | IL-8 level | 63.9 pg/ml | Standard Deviation 52.8 |
Secondary
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
Number of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Time frame: From 0 months up to 3 months post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation Plus Placebo | Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months | 6 Participants with AF recurrence |
| Ablation Plus Prednisone | Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months | 8 Participants with AF recurrence |
Secondary
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Time frame: From 3 months up to 6 months post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ablation Plus Placebo | Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months | 5 Participants with AF recurrence |
| Ablation Plus Prednisone | Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months | 9 Participants with AF recurrence |