Tricuspid Isthmus Imaged by CARTOsound, Patients With Typical Atrial Flutter

NCT ID: NCT01113788

Last Updated: 2010-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Atrial Flutter

Keywords

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atrial flutter, tricuspid isthmus, ablation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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imaging

imaging with usual catheter/fluoroscopy, no cartosound

tricuspid isthmus imaging with Cartosound

Intervention Type DEVICE

tricuspid isthmus imaging with Cartosound

Interventions

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tricuspid isthmus imaging with Cartosound

tricuspid isthmus imaging with Cartosound

Intervention Type DEVICE

Other Intervention Names

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Cartosound

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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UWO Department of Medicine

Principal Investigators

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Allan Skanes, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

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London Health Sciences Center

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Allan Skanes, MD

Role: CONTACT

Phone: 519-663-3746

Email: [email protected]

Cathy Bentley

Role: CONTACT

Phone: 519-685-8500-32835

Email: [email protected]

Other Identifiers

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16214

Identifier Type: OTHER

Identifier Source: secondary_id

R-09-414

Identifier Type: -

Identifier Source: org_study_id