Prevention of Atrial Tachycardia After a Right Atriotomy II - Full Text View

Sponsors and Collaborators:	Skejby Hospital Danish Heart Foundation
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00709384

Purpose

The investigators performed a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy and the atriotomy with the inferior caval vein to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction time between electrodes placed on both sides of the lesions is measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line are performed three month after the operation.

Condition	Intervention	Phase
Atrial Flutter	Procedure: linear lesions	Phase II

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Prevention of Atrial Tachycardia After a Right Atriotomy II

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

completeness of the lines of block [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

safety [ Time Frame: 3 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	January 2006
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.: Experimental 1. Experimental arm will be subjected to prophylactic linear lesions. There is only an intervention arm, no control arm	Procedure: linear lesions

Detailed Description:

We perform a prophylactic peroperative linear lesions connecting the tricuspid annulus with a right atriotomy (surgical dissection plus cryoablation) and the atriotomy with the inferior caval vein (cryoablation alone) to prevent atrial flutter on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction times between electrodes placed on both sides of the lesions are measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line and to try to induce atrial flutter are performed three month after the operation.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical indication for corrective operation for congenital heart disease with the use of a right lateral atriotomy,
Age >18 years,
Ability to give an informed consent.

Exclusion Criteria:

Acute operation
Chronic atrial fibrillation
Indication for MAZE procedure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00709384

Contacts

Contact: Lukac

45-8949-9078

lukac@ki.au.dk

Locations

Denmark
Skejby Hospital	Recruiting
Aarhus, Denmark
Contact: Lukac

Sponsors and Collaborators

Skejby Hospital

Danish Heart Foundation

More Information

Responsible Party:	Skejby Hospital ( Peter Lukac, MD, PhD )
Study ID Numbers:	20030198B
Study First Received:	July 1, 2008
Last Updated:	July 2, 2008
ClinicalTrials.gov Identifier:	NCT00709384
Health Authority:	Denmark: Ethics Committee

Study placed in the following topic categories:

Heart Diseases
Tachycardia
Atrial Flutter
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009