NCT02325778

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Last Updated

August 8, 2016

Status Verified

August 1, 2016

Enrollment Period

6.5 years

First QC Date

December 16, 2014

Last Update Submit

August 4, 2016

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

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

    Acute (intra procedure)

Secondary Outcomes (1)

  • Early recurrence of atrial arrhythmias

    3 months

Study Arms (2)

CTI First

EXPERIMENTAL

CTI ablation prior to left atrial ablation

Procedure: CTI ablation Timing

CTI second

EXPERIMENTAL

CTI ablation after left atrial ablation

Procedure: CTI ablation Timing

Interventions

CTI ablation TimingPROCEDURE

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

CTI FirstCTI second

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • continuous/persistent atrial fibrillation

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anthony Aizer, MD

    NYU School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 25, 2014

Study Start

January 1, 2010

Primary Completion

July 1, 2016

Last Updated

August 8, 2016

Record last verified: 2016-08

Locations

US(1)