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CompletedNCT02325778Updated Aug 8, 2016

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

A Phase 3 interventional study of CTI ablation Timing in Atrial Fibrillation, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-08-08.

Sponsored by NYU Langone Health · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
132
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Atrial Fibrillation

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03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 132 is close to the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • continuous/persistent atrial fibrillation

Exclusion criteria

Exclusion Criteria:

  • age\<18
  • congenital heart disease
  • pacemaker or ICD implant
  • previous ablation
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
132 participants (actual)

Study arms

  • Experimental
    CTI First

    CTI ablation prior to left atrial ablation

    Procedure: CTI ablation Timing

  • Experimental
    CTI second

    CTI ablation after left atrial ablation

    Procedure: CTI ablation Timing

Interventions

  • ProcedureCTI ablation Timing

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

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What researchers measure

Primary outcomes

  1. Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm

    Time frame: Acute (intra procedure)

Secondary outcomes

  1. Early recurrence of atrial arrhythmias

    Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds

    Time frame: 3 months

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Study locations

1 site
  • NYU Langone Medical Center
    New York, New York 10016, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 8, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02325778
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Dec 25, 2014
Start date
Jan 2010
Primary completion
Jul 2016
Last update
Aug 8, 2016

Study contacts

Anthony Aizer, MD
principal investigator · NYU School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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