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| Name | Class |
|---|---|
| Abbott Medical Devices | INDUSTRY |
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Radiofrequency ablation is an effective treatment for atrial fibrillation. However, about 20% of the time the atrial fibrillation recurs. Steroids given after the ablation may decrease inflammation caused by the ablation and thus improve healing and decrease the chance of recurrence of atrial fibrillation.
In this study patients will be randomized to receive intravenous steroids or not immediately following the ablation.
Atrial fibrillation, a common arrhythmia, is the source of considerable morbidity. Prevalence of atrial fibrillation in adults is 0.5%, increasing to 10% in those patients over the age of seventy five. Numbers are expected to increase nearly 2.5 fold over the next 50 years. Radiofrequency (RF) ablation to cure atrial fibrillation has become an established and effective therapy in the many atrial fibrillation patients. However, approximately 20% return with recurrent atrial fibrillation after ablation.
RF ablation directly targets the substrate for atrial fibrillation, cauterizing cardiac tissue through the application of radiofrequency energy , causing a myocardial lesion which effectively blocks the errant pathway. This process of RF ablation induces an inflammatory effect. As the lesion heals it often enlarges. This may contribute to recurrence of atrial fibrillation after ablation, as well as increased pain. There is some early evidence that a single dose of corticosteroids after ablation may improve the healing process, thus decreasing pain and incidence of recurrent atrial fibrillation.
The aim of the study is to determine the usefulness of a one time dose of solumedrol following radiofrequency ablation for atrial fibrillation..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Steroid | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Solumedrol | Drug | 100mg, given once within 2 hours of the end of the ablation procedure |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac Pain Assessment | Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) | one day and one week |
| Symptoms Post Ablation Requiring Diuretic | Occurrence of shortness of breath or edema requiring administration of a diuretic |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel P Melby, MD | Minneapolis Heart Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11282867 | Background | Grubb NR, Furniss S. Science, medicine, and the future: Radiofrequency ablation for atrial fibrillation. BMJ. 2001 Mar 31;322(7289):777-80. doi: 10.1136/bmj.322.7289.777. No abstract available. | |
| 16399094 | Background | Pappone C, Santinelli V. Atrial fibrillation ablation: state of the art. Am J Cardiol. 2005 Dec 19;96(12A):59L-64L. doi: 10.1016/j.amjcard.2005.09.063. Epub 2005 Oct 5. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Steroid | Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure |
| FG001 | Placebo | Placebo: Normal saline (1.6 cc) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Steroid | Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure |
| BG001 | Placebo | Placebo: Normal saline (1.6 cc) |
| 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 Clinically Significant Atrial Arrhythmias at 6 Weeks | Clinically significant atrial arrhythmias include ER, urgent care, or hospitalization for atrial fibrillation, cardioversion for atrial fibrillation, or atrial fibrillation requiring an increase in anti-arrhythmia medication | 3 patients lost to follow-up | Posted | Count of Participants | Participants | 6 weeks |
|
there were Adverse Events collected from six weeks to 1 year
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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 | Steroid | Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | Non-systematic Assessment |
This was a single center study trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel Melby | Minneapolis Heart Institute Foundation | 612-863-3900 | daniel.melby@allina.com |
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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 |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
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| Placebo |
| Drug |
Normal saline (1.6 cc) |
|
| 6 weeks |
| Repeat Intervention | Need for repeat ablation | 3 months |
| 14720157 | Background | Fenelon G, Franco M, Mora O, Katchburian E, de Paola AA. Combined therapy with steroids and antioxidants prevents ultrastructural damage surrounding chronic radiofrequency lesions. Pacing Clin Electrophysiol. 2004 Jan;27(1):65-72. doi: 10.1111/j.1540-8159.2004.00387.x. |
| 12975564 | Background | Fenelon G, Fernandes R, Franco M, de Paola AA. Steroids prevent late extension of radiofrequency lesions in the thigh muscle of infant rats: implications for pediatric ablation. J Interv Card Electrophysiol. 2003 Aug;9(1):7-13. doi: 10.1023/a:1025308218103. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Cardiac Pain Assessment | Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) | 4 patients lost to follow up | Posted | Mean | Standard Deviation | units on a scale | one day and one week |
|
|
|
| Secondary | Symptoms Post Ablation Requiring Diuretic | Occurrence of shortness of breath or edema requiring administration of a diuretic | Data were not collected on this outcome | Posted | 6 weeks |
|
|
| Secondary | Repeat Intervention | Need for repeat ablation | 14 patients lost to follow up | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 60 |
| 25 |
| 60 |
| EG001 | Placebo | Placebo: Normal saline (1.6 cc) | 0 | 59 | 17 | 59 |
| Chest Pain | Cardiac disorders | Non-systematic Assessment |
|
| Shortness of Breath | Cardiac disorders | Non-systematic Assessment |
|
| Fatigue | Cardiac disorders | Non-systematic Assessment |
|
| Back Pain | Cardiac disorders | Non-systematic Assessment |
|
| Edema/fluid overload | Cardiac disorders | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Abdominal Pain | Cardiac disorders | Non-systematic Assessment |
|
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |