Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01113788
Recruitment Status : Unknown
Verified April 2010 by Lawson Health Research Institute.
Recruitment status was:  Recruiting
First Posted : April 30, 2010
Last Update Posted : April 30, 2010
Johnson & Johnson
Information provided by:
Lawson Health Research Institute

Brief 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.

Condition or disease Intervention/treatment
Atrial Flutter Device: tricuspid isthmus imaging with Cartosound

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
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tricuspid Isthmus Architecture as Imaged by CARTOsound, Determines Ablation Times in Patients With Typical Atrial Flutter
Study Start Date : March 2010
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
imaging with usual catheter/fluoroscopy, no cartosound
Device: tricuspid isthmus imaging with Cartosound
tricuspid isthmus imaging with Cartosound
Other Name: Cartosound

Primary Outcome Measures :
  1. observational including ablation lesion number, ablation time in minutes, fluoroscopic [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with typical atrial flutter

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01113788

Contact: Allan Skanes, MD 519-663-3746
Contact: Cathy Bentley 519-685-8500-32835

Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5A5
Sponsors and Collaborators
Lawson Health Research Institute
Johnson & Johnson
Principal Investigator: Allan Skanes, MD, FRCPC London Health Sciences Centre

Responsible Party: Dr. Allan Skanes, UWO Department of Medicine Identifier: NCT01113788     History of Changes
Other Study ID Numbers: R-09-414
16214 ( Other Identifier: REB )
First Posted: April 30, 2010    Key Record Dates
Last Update Posted: April 30, 2010
Last Verified: April 2010

Keywords provided by Lawson Health Research Institute:
atrial flutter, tricuspid isthmus, ablation

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes