Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ablation plus prednisone

Participants undergo ablation procedure and receive predinisone at protocol determined times.

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure

Ablation Procedure

Intervention Type PROCEDURE

Atrial Fibrillation (AF) ablation

Ablation plus placebo

Participants undergo ablation procedure and receive placebo at protocol determined times.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure

Ablation Procedure

Intervention Type PROCEDURE

Atrial Fibrillation (AF) ablation

Interventions

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Prednisone

60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure

Intervention Type DRUG

Placebo

60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure

Intervention Type OTHER

Ablation Procedure

Atrial Fibrillation (AF) ablation

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No