Prevention of Atrial Tachycardia After a Right Atriotomy II

Phase 2

Completed

• Conditions: Atrial Flutter
• Interventions: Procedure: Prophylactic surgical lesion

• Registration Number: NCT00709384
• Lead Sponsor: Aarhus University Hospital Skejby

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-07-01
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-18
• Last Update Posted: 2009-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

1. Acute operation
2. Chronic atrial fibrillation
3. Indication for MAZE procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prophylactic intervention	Prophylactic surgical lesion	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

Primary Outcome Measures

Name	Time	Method
completeness of the lines of block	3 month

Secondary Outcome Measures

Name	Time	Method
safety	3 month

Trial Locations

Locations (1)

Skejby Hospital; 🇩🇰 Aarhus, Denmark