RASTA: Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation

Sponsor

University of Pennsylvania (Other)

Overall Status

Completed

CT.gov ID

NCT00379301

Collaborator

(none)

166

Enrollment

Location

Arms

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Procedure: Radiofrequency ablation	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

166 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy of Different Ablation Strategies in Achieving Long-Term Arrhythmia Control in Patients With Persistent or Permanent Atrial Fibrillation

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2009

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1 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)	Procedure: Radiofrequency ablation Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
Active Comparator: Group 2 PVI combined with ablation at documented sites of non-PV triggers, PLUS ablation at sites where non-PV triggers are commonly found	Procedure: Radiofrequency ablation Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.
Active Comparator: Group 3 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).	Procedure: Radiofrequency ablation Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.

Arm

Intervention/Treatment

Active Comparator: Group 1

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)

Procedure: Radiofrequency ablation

Special catheters are inserted into blood vessels in the groin, then advanced into the left atrium of the heart. Radiofrequency (heat) energy is applied to small areas of heart tissue where electrical impulses that generate AF are found.

Active Comparator: Group 2

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

Procedure: Radiofrequency ablation

Active Comparator: Group 3

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).

Procedure: Radiofrequency ablation

Outcome Measures

Primary Outcome Measures

Long-term (greater than 6 months) arrhythmia control in patients with persistent or permanent AF [6 - 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.