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Prevention of Atrial Tachycardia After a Right Atriotomy II

A

Aarhus University Hospital Skejby

Status and phase

Completed
Phase 2

Conditions

Atrial Flutter

Treatments

Procedure: Prophylactic surgical lesion

Study type

Interventional

Funder types

Other

Identifiers

NCT00709384
20030198B

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

Prophylactic intervention
Experimental group
Description:
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
Treatment:
Procedure: Prophylactic surgical lesion

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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