Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation (RASTA)

University of Pennsylvania

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Radiofrequency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT00379301

UPenn805173

Details and patient eligibility

About

This study involves treatment for atrial fibrillation (AF)-the most common heart condition in the US-where the upper chambers of the heart beat very fast and in a disorganized manner. This can be felt as palpitations, tiredness, shortness of breath and passing out, plus can lead to stroke, damage to the heart muscle and a shorter life span. Study participants will receive a common treatment for atrial fibrillation called radiofrequency ablation (RFA), where small lesions or "burns" are made inside the heart to cut off the abnormal impulses that cause AF. The purpose of this study is to compare the effectiveness of three different common ablation strategies in patients with persistent or permanent AF. Subjects will be randomized (like drawing straws) to be treated with one of the three strategies to see if there is a difference in how well atrial fibrillation is controlled after treatment.

Full description

In most cases, AF originates where the pulmonary veins (PV) enter the left upper chamber of the heart, known as the left atrium (LA). Common to the procedure in each arm of the study is pulmonary vein isolation (PVI) or ablation of tissue around the pulmonary vein entrances. After PVI, the procedure continues with ablation in other areas of the LA where similar abnormal impulses are found. The three strategies for continuing with ablation after PVI are described in the "Arms" section below.

Enrollment: 166 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients of age ≥ 30 years, undergoing their first ablation procedure that meet ACC / AHA defined criteria for persistent or permanent AF will be eligible to participate in the study. This includes patients with a history of AF episodes lasting at least 7 days or requiring at least 2 cardioversions.

Exclusion criteria

1. Patients with paroxysmal AF (self-terminating episodes lasting < 7 day)
2. Patients who have had a previous AF ablation procedure
3. Pregnancy
4. Failure to obtain informed consent
5. Less than 30 years old

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 3 patient groups

Group 1

Active Comparator group

Description:

Pulmonary vein isolation (PVI) combined with ablation of documented non-PV triggers of atrial fibrillation --- (sites away from the pulmonary veins where consistent abnormal impulses that can trigger AF are identified during the procedure)

Treatment:

Procedure: Radiofrequency ablation

Group 2

Active Comparator group

Description:

PVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found

Treatment:

Procedure: Radiofrequency ablation

Group 3

Active Comparator group

Description:

PVI combined with ablation at documented sites of non-PV triggers and ablation at sites in the left atrium that demonstrate disorganized electrical impulses called complex fractionated electrograms (CFE).

Treatment:

Procedure: Radiofrequency ablation