Maximum Targeted Ablation of Atrial Flutter | NCT00491010

Studies
Maximum Targeted Ablation of Atrial Flutter

NCT00491010

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Unknown status

Last Update Posted

Jun 25, 2007Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Atrial Flutter

Interventions

radiofrequency catheter ablation

Countries

Canada

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

ID	Type	Description	Link
12266

Status Module

Record Verification Date

Jun 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Feb 2008Estimated

First Submitted Date

Jun 21, 2007

First Submission Date that Met QC Criteria

Jun 21, 2007

First Posted Date

Jun 25, 2007Estimated

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

Jun 21, 2007

Last Update Posted Date

Jun 25, 2007Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

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

Patients undergoing atrial flutter ablation will be randomized to either the standard ablation approach or voltage targeted approach. Patients will be followed for one year to assess outcome of the ablation technique

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency catheter ablation	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients undergoing TV-IVC isthmus ablatin for atrial flutter

Exclusion Criteria:

atypical atrial flutter
<18 years old any atrial surgery or pacemaker refusal to participate

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

Name	Role	Phone	Extension	Email
Allan Skanes, MD	Contact	519-685-8500	32739	askanes@uwo.ca
Lorne gula, MD	Contact	519 685-8500	32739	lgula@uwo.ca

Overall Officials

Name	Affiliation	Role
Allan c Skanes, MD	University of Western Ontario, London Health Sciences Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
London Health Sciences Center	Recruiting	London	Ontario	N6A 5A5	Canada

Condition Browse Module

MeSH Terms

ID	Term
D001282	Atrial Flutter

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017115	Catheter Ablation

Ancestor Terms

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques

Browse Leaves

Not provided

Browse Branches

Not provided