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Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

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ClinicalTrials.gov 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
Sponsor:
Collaborator:
Information provided by:

Study Description
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 Design

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

U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01113788


Contacts
Contact: Allan Skanes, MD 519-663-3746 askanes@uwo.ca
Contact: Cathy Bentley 519-685-8500-32835 cbentl@uwo.ca

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

Responsible Party: Dr. Allan Skanes, UWO Department of Medicine
ClinicalTrials.gov 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