Comparison of CTI Ablation Prior to or After LA Ablation... | NCT02325778

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

NCT02325778

Sponsor

NYU Langone Health

Status

Completed

Last Update Posted

Aug 8, 2016Estimated

Enrollment

132Actual

Phase

Phase 3

Conditions

Atrial Fibrillation

Interventions

CTI ablation Timing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jul 2016Actual

Completion Date

Not provided

First Submitted Date

Dec 16, 2014

First Submission Date that Met QC Criteria

Dec 24, 2014

First Posted Date

Dec 25, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2016

Last Update Posted Date

Aug 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

132Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
CTI ablation Timing	Procedure	The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.	CTI First CTI second

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Ablation Lines Required to Organize Atrial Fibrillation to an Atrial Tachycardia or Sinus Rhythm		Acute (intra procedure)

Secondary Outcomes

Measure	Description	Time Frame
Early recurrence of atrial arrhythmias	Atrial Fibrillation or Atrial Tachycardia lasting longer than 30 seconds	3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

continuous/persistent atrial fibrillation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anthony Aizer, MD	NYU School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Medical Center		New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D001281	Atrial Fibrillation

Ancestor Terms

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided