NCT00247351

Brief Summary

We performed a prophylactic peroperative linear 1-minute cryolesion connecting the tricuspid annulus and right atriotomy to prevent IART on 15 consecutive adult patients undergoing surgery for congenital heart disease. Conduction time between electrodes placed on both sides of the cryolesion was measured on the second postoperative day. Coronary angiography and electrophysiology study using an electroanatomic mapping system to assess conduction across the line were performed three month after the operation on 13 patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 1, 2005

Completed
Last Updated

October 19, 2006

Status Verified

September 1, 2003

First QC Date

October 31, 2005

Last Update Submit

October 18, 2006

Conditions

Atrial Tachycardia

Outcome Measures

Primary Outcomes (2)

  • Feasibility of creation of a complete line of block

  • Safety

Interventions

CryoablationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Acute operation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skejby Hospital

Aarhus, Denmark

Location

MeSH Terms

Interventions

Cryosurgery

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Peter Lukac, MD

    Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 31, 2005

First Posted

November 1, 2005

Study Start

September 1, 2003

Study Completion

June 1, 2005

Last Updated

October 19, 2006

Record last verified: 2003-09

Locations

DK(1)