Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Corticosteroid, Radiofrequency catheter ablation for atrial fibrillation
Brief summary
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.
Detailed description
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..
Interventions
DRUGSolumedrol
100mg, given once within 2 hours of the end of the ablation procedure
DRUGPlacebo
Normal saline (1.6 cc)
Sponsors
Abbott Medical Devices
Minneapolis Heart Institute Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 * Drug refractory, symptomatic paroxysmal atrial fibrillation
Exclusion criteria
* Contraindication to solumedrol * Persistent or permanent Atrial Fibrillation * Previous history of radiofrequency ablation for atrial fibrillation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Pain Assessment | one day and one week | Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable) |
| Symptoms Post Ablation Requiring Diuretic | 6 weeks | Occurrence of shortness of breath or edema requiring administration of a diuretic |
| Repeat Intervention | 3 months | Need for repeat ablation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Steroid Solumedrol: 100mg, given once within 2 hours of the end of the ablation procedure | 60 |
| Placebo Placebo: Normal saline (1.6 cc) | 59 |
| Total | 119 |
Baseline characteristics
| Characteristic | Steroid | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 60.3 years STANDARD_DEVIATION 10.2 | 60.0 years STANDARD_DEVIATION 11.4 | 60.1 years STANDARD_DEVIATION 11.2 |
| Sex/Gender, Customized Female | 14 participants | 13 participants | 27 participants |
| Sex/Gender, Customized Male | 46 participants | 46 participants | 92 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 25 / 60 | 17 / 59 |
| serious Total, serious adverse events | 0 / 60 | 0 / 59 |
Outcome results
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
Time frame: 6 weeks
Population: 3 patients lost to follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steroid | Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | 4 Participants |
| Placebo | Number of Participants With Clinically Significant Atrial Arrhythmias at 6 Weeks | 12 Participants |
Secondary
Cardiac Pain Assessment
Perception of cardiac pain assessed by a numerical pain scale (0= no pain; 10=worst pain imaginable)
Time frame: one day and one week
Population: 4 patients lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Steroid | Cardiac Pain Assessment | Pain Scale Day 1 | 0.9 units on a scale | Standard Deviation 1.5 |
| Steroid | Cardiac Pain Assessment | Pain Scale Week 1 | 0.8 units on a scale | Standard Deviation 1.9 |
| Placebo | Cardiac Pain Assessment | Pain Scale Day 1 | 1.5 units on a scale | Standard Deviation 2.4 |
| Placebo | Cardiac Pain Assessment | Pain Scale Week 1 | 0.6 units on a scale | Standard Deviation 1.2 |
Secondary
Repeat Intervention
Need for repeat ablation
Time frame: 3 months
Population: 14 patients lost to follow up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Steroid | Repeat Intervention | 2 Participants |
| Placebo | Repeat Intervention | 8 Participants |
Secondary
Symptoms Post Ablation Requiring Diuretic
Occurrence of shortness of breath or edema requiring administration of a diuretic
Time frame: 6 weeks
Population: Data were not collected on this outcome