Back to resultsComparison of CTI Ablation Prior to or After LA Ablation for AF
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CTI ablation Timing
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- continuous/persistent atrial fibrillation
Exclusion Criteria:
- age<18
- congenital heart disease
- pacemaker or ICD implant
- previous ablation
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CTI First
CTI second
Arm Description
CTI ablation prior to left atrial ablation
CTI ablation after left atrial ablation
Outcomes
Primary Outcome Measures
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
Secondary Outcome Measures
Early recurrence of atrial arrhythmias
Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02325778
Brief Title
Comparison of CTI Ablation Prior to or After LA Ablation for AF
Official Title
Randomized, Single-blind, Comparative Trial of Two AF Ablation Strategies (CTI Ablation Prior to LA Ablation Versus CTI After LA Ablation) to Eliminate Persistent AF
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to determine if CTI prior to CPVA/PVI/Linear Lesions/Fractionation results in reduced left atrial ablation lesion sets prior to restoration of sinus rhythm in patients with long standing persistent atrial fibrillation in the absence of antiarrhythmic drug therapy compared to CTI after CPVA/PVI/Linear Lesions/Fractionation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CTI First
Arm Type
Experimental
Arm Description
CTI ablation prior to left atrial ablation
Arm Title
CTI second
Arm Type
Experimental
Arm Description
CTI ablation after left atrial ablation
Intervention Type
Procedure
Intervention Name(s)
CTI ablation Timing
Intervention Description
The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.
Primary Outcome Measure Information:
Title
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
Time Frame
Acute (intra procedure)
Secondary Outcome Measure Information:
Title
Early recurrence of atrial arrhythmias
Description
Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
continuous/persistent atrial fibrillation
Exclusion Criteria:
age<18
congenital heart disease
pacemaker or ICD implant
previous ablation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Aizer, MD
Organizational Affiliation
NYU School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of CTI Ablation Prior to or After LA Ablation for AF
We'll reach out to this number within 24 hrs