Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Lawson Health Research Institute.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01113788
First received: January 11, 2010
Last updated: April 29, 2010
Last verified: April 2010
  Purpose

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 Intervention
Atrial Flutter
Device: tricuspid isthmus imaging with Cartosound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tricuspid Isthmus Architecture as Imaged by CARTOsound, Determines Ablation Times in Patients With Typical Atrial Flutter

Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • observational including ablation lesion number, ablation time in minutes, fluoroscopic [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2010
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
imaging
imaging with usual catheter/fluoroscopy, no cartosound
Device: tricuspid isthmus imaging with Cartosound
tricuspid isthmus imaging with Cartosound
Other Name: Cartosound

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Allan Skanes, UWO Department of Medicine
ClinicalTrials.gov Identifier: NCT01113788     History of Changes
Other Study ID Numbers: R-09-414, 16214
Study First Received: January 11, 2010
Last Updated: April 29, 2010
Health Authority: Canada: Ethics Review Committee

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

ClinicalTrials.gov processed this record on July 31, 2014