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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by University of Pennsylvania
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01710150
First received: October 11, 2012
Last updated: October 30, 2013
Last verified: September 2012

October 11, 2012
October 30, 2013
November 2012
December 2015   (final data collection date for primary outcome measure)
Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01710150 on ClinicalTrials.gov Archive Site
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 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
 
Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter
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).

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Patients With Typical Aflutter and Manifest Risk Factors With Future Development of AF.
  • Procedure: CTI ablation alone
  • Procedure: CTI ablation and Pulmonary vein isolation (PVI)
  • Placebo Comparator: CTI ablation only
    subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Aflutter
    Intervention: Procedure: CTI ablation alone
  • Active Comparator: CTI ablation and PVI.
    subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Aflutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
    Intervention: Procedure: CTI ablation and Pulmonary vein isolation (PVI)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
Not Provided
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact: Mary Gnap 215 349 8446 gnapm@uphs.upenn.edu
United States
 
NCT01710150
REDUCE AF
Yes
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: Sanjay Dixit, MD University of Pennsylvania
University of Pennsylvania
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP