- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02325778
Comparison of CTI Ablation Prior to or After LA Ablation for AF
August 4, 2016 updated by: NYU Langone Health
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
132
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- continuous/persistent atrial fibrillation
Exclusion Criteria:
- age<18
- congenital heart disease
- pacemaker or ICD implant
- previous ablation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CTI First
CTI ablation prior to left atrial ablation
|
The timing of when the CTI ablation is performed.
There are no other relevant interventions used in the procedure.
|
Experimental: CTI second
CTI ablation after left atrial ablation
|
The timing of when the CTI ablation is performed.
There are no other relevant interventions used in the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm
Time Frame: Acute (intra procedure)
|
Acute (intra procedure)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early recurrence of atrial arrhythmias
Time Frame: 3 months
|
Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anthony Aizer, MD, NYU School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
December 24, 2014
First Posted (Estimate)
December 25, 2014
Study Record Updates
Last Update Posted (Estimate)
August 8, 2016
Last Update Submitted That Met QC Criteria
August 4, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-01007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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