Prevention of Atrial Tachycardia After a Right Atriotomy II

Sponsor

Aarhus University Hospital Skejby (Other)

Overall Status

Completed

CT.gov ID

NCT00709384

Collaborator

Danish Heart Foundation (Other)

Enrollment

Location

Arm

37.9

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Flutter	Procedure: Prophylactic surgical lesion	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Prevention of Atrial Tachycardia After a Right Atriotomy II

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prophylactic intervention 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 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).

Arm

Intervention/Treatment

Experimental: Prophylactic intervention

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

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).

Outcome Measures

Primary Outcome Measures

completeness of the lines of block [3 month]

Secondary Outcome Measures

safety [3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Skejby Hospital	Aarhus		Denmark

Sponsors and Collaborators

Aarhus University Hospital Skejby
Danish Heart Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00709384

Other Study ID Numbers:

20030198B

First Posted:

Jul 3, 2008

Last Update Posted:

Sep 21, 2009

Last Verified:

Sep 1, 2009

Additional relevant MeSH terms:

Tachycardia

Atrial Flutter

Study Results

No Results Posted as of Sep 21, 2009