Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

Atrial Flutter Clinical Trial

Official title:

Tricuspid Isthmus Architecture as Imaged by CARTOsound, Determines Ablation Times in Patients With Typical Atrial Flutter

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01113788
• Other study ID #: R-09-414
• Secondary ID: 16214
• Status: Recruiting
• Phase: N/A
• First received: January 11, 2010
• Last updated: April 29, 2010
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: April 2010
• Source: Lawson Health Research Institute
• Contact: Allan Skanes, MD
• Phone: 519-663-3746
• Email: askanes[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The investigators propose a third hypothesis based on the anatomic observations made in pathological studies. The investigators hypothesize that the anatomic architecture determines the functional properties of the TV-IVC isthmus. As a result,

• Muscular bundles are preferential routes of conduction through the TV-IVC isthmus. The isthmus acts like a series of discreet conduction routes rather than as a sheet of tissue.

The muscular bundles form selective targets for ablation and therefore the entire anatomic line need not be ablated. This has direct implications for ablation of the isthmus.

Description:

Patients undergoing atrial flutter ablation will have cartosound imaging done during procedure to determine if this will shorten ablation times.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must be over 18 years of age provided written informed consent documented atrial flutter by ECG , holter monitor or TTM

Exclusion Criteria:

• previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Flutter

Intervention

Device:
• tricuspid isthmus imaging with Cartosound
tricuspid isthmus imaging with Cartosound

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Johnson & Johnson

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	observational including ablation lesion number, ablation time in minutes, fluoroscopic		12 months	No