Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter

Study Overview
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Brief Summary
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The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).

Detailed Description
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Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.

Official Title
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Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).

Conditions
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Typical Atrial Flutter, Risk Factors With Future Development of Atrial Flutter

Intervention / Treatment
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* Procedure: CTI ablation alone
* Procedure: CTI ablation and Pulmonary vein isolation (PVI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with typical AFLT confirmed by a 12-lead ECG that are referred for ablation and manifest ≥ 2 risk factors associated with future development of AF will be eligible to participate in the study. Risk factors for predicting future occurrence of AF will include: prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation), LA size > 4.0 cm, left ventricular ejection fraction (LVEF) ≤ 50%, hypertension, and/or 5) obstructive sleep apnea. Exclusion Criteria: Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment, inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and failure to provide informed consent.

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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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: CTI ablation only<br>subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter | Procedure: CTI ablation alone<br> <br> |
| Active Comparator: CTI ablation and PVI.<br>subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation. | Procedure: CTI ablation and Pulmonary vein isolation (PVI)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: 1) Long-term ( 2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI