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

Not Applicable

Withdrawn

• Conditions: Typical Atrial Flutter; Risk Factors With Future Development of Atrial Flutter
• Interventions: Procedure: CTI ablation alone; Procedure: CTI ablation and Pulmonary vein isolation (PVI)

• Registration Number: NCT01710150
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-10-11
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-18
• Study Start: 2012-11
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-28
• Last Update Posted: 2017-05-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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:

1. prior remote history of AF (≤ 2 episodes ≥ 1 year from the date of evaluation for study participation),
2. LA size > 4.0 cm,
3. left ventricular ejection fraction (LVEF) ≤ 50%,
4. hypertension, and/or 5) obstructive sleep apnea.

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Exclusion Criteria

1. Subjects with documented ≥ 2 AF episodes within the preceding 6 months of enrollment,
2. inability or unwillingness to take 6 weeks of oral anticoagulation after the procedure and
3. failure to provide informed consent.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CTI ablation only	CTI ablation alone	subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
CTI ablation and PVI.	CTI ablation and Pulmonary vein isolation (PVI)	subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.

Primary Outcome Measures

Name	Time	Method
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).	2 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States