Comparison of PVI Plus Catheter Ablation or PVI Alone for the Treatment of AFib for Patients With Paroxysmal Atrial Fibrillation

Study Overview
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Brief Summary
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There is a need to compare the efficacy of PVI versus PVI plus catheter ablation, which includes ablation of complex fractionated atrial electrograms (CFAE) and linear lesions in the same procedure. If it is found that the PVI alone is as effective as PVI plus catheter ablation of CFAE and linear lesions, it may reduce the need for catheter ablation.

Official Title
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Comparison of Pulmonary Vein Isolation Plus Additional Catheter Ablation or Pulmonary Vein Isolation Alone for the Treatment of Atrial Fibrillation for Patients With Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: PVI Plus Catheter Ablation
* Procedure: PVI Alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (Step 1 - Registration) The subject is 18 years of age or older Left atrium < 6.0 cm (Trans Thoracic Echo - TTE - parasternal 4 chamber view performed within 6 months) Documentation of AF that terminates spontaneously or with intervention within 7 days of onset (PAF) Failed or refractory to one AAD (class I and/or III) Provided written informed consent Be eligible for an AF ablation procedure for Paroxysmal AF (Step 2 - Randomization) Sustained AF following PVI with ability to receive additional linear or focal intracardiac catheter ablation Exclusion Criteria: (Step 1 - Registration) Pregnant or planning to become pregnant during study Co-morbid medical conditions that limit one-year life expectancy Previous cardiac surgery Patients who have active infection or sepsis Patients with esophageal ulcers strictures and varices Patients who are contraindicated for anticoagulants such as heparin and warfarin Patients who are being treated for ventricular arrhythmias Patients who have had a previous left atrial catheter ablation for AF (does not include ablation for AFL or other supraventricular arrhythmias) Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) (Step 2 Randomization) Not able to receive additional linear or focal intracardiac catheter ablation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PVI Plus Catheter Ablation<br>Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF. | Procedure: PVI Plus Catheter Ablation<br>* Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.<br>|
| Active Comparator: PVI Alone<br>Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF. | Procedure: PVI Alone<br>* Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence | Any atrial fibrillation/atrial tachycardia/atrial flutter following the blanking period. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recurrence following intervention | Time to recurrence following intervention | 12 months post intervention |