Comparison of CTI Ablation Prior to or After LA Ablation for AF

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02325778
• Other study ID #: 10-01007
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2014
• Last updated: August 4, 2016
• Start date: January 2010

Study information

• Verified date: August 2016
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• continuous/persistent atrial fibrillation

Exclusion Criteria:

• age<18

• congenital heart disease

• pacemaker or ICD implant

• previous ablation

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• CTI ablation Timing
The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.

Locations

Country	Name	City	State
United States	NYU Langone Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm		Acute (intra procedure)	No
Secondary	Early recurrence of atrial arrhythmias	Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds	3 months	No