Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter (REDUCE AF)

University of Pennsylvania

Status: Withdrawn

Conditions: Typical Atrial Flutter; Risk Factors With Future Development of Atrial Flutter

Treatments: Procedure: CTI ablation and Pulmonary vein isolation (PVI); Procedure: CTI ablation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT01710150

REDUCE AF

Details and patient eligibility

About

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).

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

CTI ablation only

Placebo Comparator group

Description:

subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter

Treatment:

Procedure: CTI ablation alone

CTI ablation and PVI.

Active Comparator group

Description:

subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.

Treatment:

Procedure: CTI ablation and Pulmonary vein isolation (PVI)