Prevention of Atrial Tachycardia After a Right Atriotomy II

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Atrial Tachycardia After a Right Atriotomy II

Conditions
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Atrial Flutter

Intervention / Treatment
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* Procedure: Prophylactic surgical lesion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prophylactic intervention<br>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 | Procedure: Prophylactic surgical lesion<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completeness of the lines of block |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety |  | 3 month |