Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes

Dhanunjaya Lakkireddy, MD, FACC

Status and phase: Completed; Phase 4

Conditions: Atrial Fibrillation

Treatments: Procedure: Ablation Procedure; Other: Placebo; Drug: Prednisone

Study type: Interventional

Funder types: Other

Identifiers

NCT01206452

12153

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Ablation plus prednisone

Experimental group

Description:

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

Treatment:

Procedure: Ablation Procedure

Drug: Prednisone

Ablation plus placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo

Procedure: Ablation Procedure