Risk Factors With Future Development of Atrial Flutter, Typical Atrial Flutter
Conditions
Keywords
typical aflutter (AFLT), CTI ablation, Atrial Fibrillation (AF), PVI
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.
Interventions
PROCEDURECTI ablation alone
PROCEDURECTI ablation and Pulmonary vein isolation (PVI)
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). | 2 years |
Secondary
| Measure | 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 |
Other
| Measure | Time frame |
|---|---|
| Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation. | 2 years |
Countries
United States
Outcome results
None listed