Prevention of Atrial Tachycardia After a Right Atriotomy II

Atrial Flutter Clinical Trial

Official title:

Prevention of Atrial Tachycardia After a Right Atriotomy II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00709384
• Other study ID #: 20030198B
• Status: Completed
• Phase: Phase 2
• First received: July 1, 2008
• Last updated: September 18, 2009
• Start date: January 2006
• Est. completion date: March 2009

Study information

• Verified date: September 2009
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter
• Tachycardia

Intervention

Procedure:
• Prophylactic surgical lesion
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).

Locations

Country	Name	City	State
Denmark	Skejby Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Danish Heart Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	completeness of the lines of block		3 month	No
Secondary	safety		3 month	Yes