Prevention of Atrial Tachycardia After a Right Atriotomy II
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Prophylactic surgical lesion
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter
Eligibility 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
Sites / Locations
- Skejby Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prophylactic intervention
Arm Description
We performed 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). 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. There is only an intervention arm, no control arm
Outcomes
Primary Outcome Measures
completeness of the lines of block
Secondary Outcome Measures
safety
Full Information
NCT ID
NCT00709384
First Posted
July 1, 2008
Last Updated
September 18, 2009
Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00709384
Brief Title
Prevention of Atrial Tachycardia After a Right Atriotomy II
Official Title
Prevention of Atrial Tachycardia After a Right Atriotomy II
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aarhus University Hospital Skejby
Collaborators
Danish Heart Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prophylactic intervention
Arm Type
Experimental
Arm Description
We performed 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). 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.
There is only an intervention arm, no control arm
Intervention Type
Procedure
Intervention Name(s)
Prophylactic surgical lesion
Intervention Description
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).
Primary Outcome Measure Information:
Title
completeness of the lines of block
Time Frame
3 month
Secondary Outcome Measure Information:
Title
safety
Time Frame
3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Skejby Hospital
City
Aarhus
Country
Denmark
12. IPD Sharing Statement
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Prevention of Atrial Tachycardia After a Right Atriotomy II
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