Clinical trial NCT01710150: Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
Official title: 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).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Typical Atrial Flutter
Risk Factors With Future Development of Atrial Flutter
Keywords: typical aflutter (AFLT)
CTI ablation
Atrial Fibrillation (AF)
PVI
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2012-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs).
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 2 years
Other outcomes:
measure: Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation.
timeFrame: 2 years
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Sanjay Dixit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mohanty S, Natale A, Mohanty P, DI Biase L, Trivedi C, Santangeli P, Bai R, Burkhardt JD, Gallinghouse GJ, Horton R, Sanchez JE, Hranitzky PM, Al-Ahmad A, Hao S, Hongo R, Beheiry S, Pelargonio G, Forleo G, Rossillo A, Themistoclakis S, Casella M, Russo AD, Tondo C, Dixit S. Pulmonary Vein Isolation to Reduce Future Risk of Atrial Fibrillation in Patients Undergoing Typical Flutter Ablation: Results from a Randomized Pilot Study (REDUCE AF). J Cardiovasc Electrophysiol. 2015 Aug;26(8):819-825. doi: 10.1111/jce.12688. Epub 2015 May 26.