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
  Purpose

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).


Condition Intervention
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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).

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: CTI ablation only
subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Aflutter
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.
Procedure: CTI ablation and 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01710150

Contacts
Contact: Mary Gnap 215 349 8446 gnapm@uphs.upenn.edu

Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Sanjay Dixit, MD       sanjay.dixit@uphs.upenn.edu   
Principal Investigator: Sanjay Dixit, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Sanjay Dixit, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01710150     History of Changes
Other Study ID Numbers: REDUCE AF
Study First Received: October 11, 2012
Last Updated: October 30, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
typical aflutter (AFLT)
CTI ablation
Atrial Fibrillation (AF)
PVI

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014