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

  • United States
    • 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
Procedure: CTI ablation Timing
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
Procedure: CTI ablation Timing
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

NYU Langone Health

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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