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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01710150
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : October 18, 2012
Last Update Posted : May 2, 2017
Information provided by (Responsible Party):
University of Pennsylvania

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).

Condition or disease Intervention/treatment Phase
Typical Atrial Flutter Risk Factors With Future Development of Atrial Flutter Procedure: CTI ablation alone Procedure: CTI ablation and Pulmonary vein isolation (PVI) Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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).
Study Start Date : November 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: CTI ablation only
subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Atrial flutter
Procedure: CTI ablation alone
Active Comparator: CTI ablation and PVI.
subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Atrial flutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
Procedure: CTI ablation and Pulmonary vein isolation (PVI)

Primary Outcome Measures :
  1. Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01710150

United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Principal Investigator: Sanjay Dixit, MD University of Pennsylvania

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Pennsylvania Identifier: NCT01710150     History of Changes
Other Study ID Numbers: REDUCE AF
First Posted: October 18, 2012    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017

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

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