Prevention of Atrial Tachycardia After a Right Atriotomy II
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jan 2006
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 1, 2008
CompletedFirst Posted
Study publicly available on registry
July 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedSeptember 21, 2009
September 1, 2009
3.2 years
July 1, 2008
September 18, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
completeness of the lines of block
3 month
Secondary Outcomes (1)
safety
3 month
Study Arms (1)
Prophylactic intervention
EXPERIMENTALWe 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
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Acute operation
- Chronic atrial fibrillation
- Indication for MAZE procedure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aarhus University Hospital Skejbylead
- Danish Heart Foundationcollaborator
Study Sites (1)
Skejby Hospital
Aarhus, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 1, 2008
First Posted
July 3, 2008
Study Start
January 1, 2006
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
September 21, 2009
Record last verified: 2009-09