NCT01113788

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 30, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 30, 2010

Status Verified

April 1, 2010

Enrollment Period

9 months

First QC Date

January 11, 2010

Last Update Submit

April 29, 2010

Conditions

Keywords

atrial flutter, tricuspid isthmus, ablation

Outcome Measures

Primary Outcomes (1)

  • observational including ablation lesion number, ablation time in minutes, fluoroscopic

    12 months

Study Arms (1)

imaging

imaging with usual catheter/fluoroscopy, no cartosound

Device: tricuspid isthmus imaging with Cartosound

Interventions

tricuspid isthmus imaging with Cartosound

Also known as: Cartosound
imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with typical atrial flutter

You may qualify if:

  • Patients must be over 18 years of age provided written informed consent documented atrial flutter by ECG , holter monitor or TTM

You may not qualify if:

  • previous atrial flutter ablation non isthmus dependent atrial flutter prior right atrial surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Flutter

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Allan Skanes, MD, FRCPC

    London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Allan Skanes, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

April 30, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 30, 2010

Record last verified: 2010-04

Locations