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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.
The purpose of this study is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ablation plus prednisone | Experimental | Participants undergo ablation procedure and receive predinisone at protocol determined times. |
|
| Ablation plus placebo | Placebo Comparator | Participants undergo ablation procedure and receive placebo at protocol determined times. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug | 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 6 months up to 12 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From 0 months up to 3 months post procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dhanunjaya Lakkireddy, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ablation Plus Prednisone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | Participants with AF recurrence | From 6 months up to 12 months post-procedure |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Groin hematoma | Blood and lymphatic system disorders | Non-systematic Assessment | Related to ablation procedure. No subjects required blood transfusions or surgical repair. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donita Atkins, RN, CCRC | University of Kansas Medical Center | (913) 588-9714 | datkins2@kumc.edu |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Placebo | Other | 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure |
|
| Ablation Procedure | Procedure | Atrial Fibrillation (AF) ablation |
|
| 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. | From 3 months up to 6 months post-procedure |
| 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. | Immediately Post-Ablation Procedure |
| 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. | 24 Hours after Ablation Procedure |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| AF Duration | Mean | Standard Deviation | years |
|
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
|
|
| 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. | Posted | Number | Participants with AF recurrence | From 0 months up to 3 months post procedure |
|
|
|
| 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. | Posted | Number | Participants with AF recurrence | From 3 months up to 6 months post-procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pg/ml | Immediately Post-Ablation Procedure |
|
|
|
| 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. | Posted | Mean | Standard Deviation | pg/ml | 24 Hours after Ablation Procedure |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| EG001 | 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 | 0 | 30 | 2 | 30 |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| TNF-α level |
|
| IL-6 level |
|
| TNF-α level |
|
| IL-6 level |
|