Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

April 29, 2010 updated by: Lawson Health Research Institute

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with typical atrial flutter

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
imaging
imaging with usual catheter/fluoroscopy, no cartosound
Device: tricuspid isthmus imaging with Cartosound
tricuspid isthmus imaging with Cartosound
Other Names:
  • Cartosound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
observational including ablation lesion number, ablation time in minutes, fluoroscopic
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Johnson & Johnson

Investigators

  • Principal Investigator: Allan Skanes, MD, FRCPC, London Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2010

Study Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

April 29, 2010

First Posted (Estimate)

April 30, 2010

Study Record Updates

Last Update Posted (Estimate)

April 30, 2010

Last Update Submitted That Met QC Criteria

April 29, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-09-414
  • 16214 (Other Identifier: REB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe