Atrial TachycardiaNCT00247351
Prevention of Atrial Tachycardia After a Right Atriotomy
A study testing Cryoablation in people with Atrial Tachycardia, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Tachycardia
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2003to Jun 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were: 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.
Who cannot join
- Acute operation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Patient selection Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were: 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. The only exclusion criterion was acute operation.
Written informed consent was obtained from all the patients prior to the inclusion in the study. The ethical committee for Aarhus County approved the study September 18, 2003.
Operation and postoperative care The operation was performed in the usual fashion. Additionally, a single linear endocardial 1-minute cryolesion connecting the right lateral atriotomy with the tricuspid annulus anteriorly and with crista terminalis posteriorly was performed before the right atriotomy has been sutured (Figure 1). SurgiFrost® cryosurgical probe (Endocare Inc., Irvine, California) was used. Two pairs of epicardial electrodes were placed on the atrium between the incision and the tricuspid annulus 1.5 cm cranially, and caudally from the cryolesion at the end of the repair. They were brought out together to the thorax on the patient's right side. Subsequently, the thorax was closed in the usual way.
Patients were monitored continuously using bedside monitors or telemetry for the first 16-24 hours after the operation. A 12-lead electrocardiogram (ECG) was obtained at any clinical suspicion of arrhythmia. Atrial tachycardia was defined as a sustained regular monomorphic atrial rhythm at a constant rate >100/min originating outside the sinus node.
Measurement of conduction time On the second postoperative day, the conduction time was measured with the help of pacing the electrode pair on the one side of the cryolesion between the incision and the tricuspid annulus and sensing the unipolar signals on the other side (Figure 2). Signals were recorded at 100 mm/s using a commercially available ECG machine.
Electrophysiology study and coronary angiography Electrophysiology study and coronary angiography were carried out 3 months after the operation. Patients were free of antiarrhythmic agents at the time of the study. Coronary angiography was performed with the usual technique from the femoral approach. Afterwards, a 7-French quadripolar deflectable ablation catheter with a 4-mm tip electrode (Navistar®, Biosense Webster, Diamond Bar, California) was advanced via the right femoral vein into the right atrium for mapping and radiofrequency catheter ablation. An active fixation lead (Sweet Picotip®, Guidant, St. Paul, Minnesota) was screwed in the lateral right atrium near the tricuspid annulus and the performed cryolesion and was used for pacing. Simultaneous recordings of intracardiac electrograms filtered at 50-500 Hz and 12-lead surface ECG were stored digitally (CardioLab®, Prucka Engineering, Inc., Houston, Texas or Prucka CardioLab 2000®, GE Medical Systems, Milwaukee, Wisconsin). An electroanatomic map (CARTO®, Biosense Webster, Diamond Bar, California) was constructed during pacing with special emphasis on the region of surgical scar and cryolesion to be able to judge conduction across the cryolesion. Afterwards, the active fixation lead was repositioned to the opposite side of the cryolesion near the Navistar® catheter, which was placed with the help of the already constructed electroanatomic map. Another electroanatomic map was created under pacing from this second site to judge the completeness of the cryolesion in the other direction. Afterwards, attempts at induction of atrial arrhythmias were made. These included rapid atrial pacing with 20 stimuli starting from a cycle length of 400 ms with 20 ms decrements down to a cycle length of 200 ms, and single and double extrastimuli at 400 ms cycle length down to atrial refractoriness. Isoproterenol was not used during the study.
Safety assessment of the intervention All adverse events were recorded. Likely relationship of adverse events to the study intervention was determined based on the consensus of the participating investigators.
Statistical analysis All calculations were carried out using the statistical software Intercooled Stata® Release 8 (Stata Corporation, College Station, Texas). Comparison of continuous variables was performed using the Student's t-test, or the Wilcoxon rank-sum test, as appropriate. Comparison of proportions was performed using the Fisher's exact test. Median (interquartile range) or mean ± standard deviation are reported, as appropriate.
- Conditions
- Atrial Tachycardia
- Being tested
- Cryoablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of creation of a complete line of block
Safety
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startSep 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Investigators
- Peter Lukac, MD, Principal investigator, Aarhus University Hospital Skejby
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247351
- Sponsor's protocol ID
- 20030198
- Status last verified
- Sep 2003
- First submitted
- 31 Oct 2005
- Last updated
- 19 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Atrial Tachycardia After a Right Atriotomy
- ClinicalTrials.gov ID
- NCT00247351
- Acronym / sponsor ID
- 20030198
- Conditions
- Atrial Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- Sep 2003
- Study completion
- Jun 2005
- First posted
- 1 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patient selection Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were: 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. The only exclusion criterion was acute operation.
Written informed consent was obtained from all the patients prior to the inclusion in the study. The ethical committee for Aarhus County approved the study September 18, 2003.
Operation and postoperative care The operation was performed in the usual fashion. Additionally, a single linear endocardial 1-minute cryolesion connecting the right lateral atriotomy with the tricuspid annulus anteriorly and with crista terminalis posteriorly was performed before the right atriotomy has been sutured (Figure 1). SurgiFrost® cryosurgical probe (Endocare Inc., Irvine, California) was used. Two pairs of epicardial electrodes were placed on the atrium between the incision and the tricuspid annulus 1.5 cm cranially, and caudally from the cryolesion at the end of the repair. They were brought out together to the thorax on the patient's right side. Subsequently, the thorax was closed in the usual way.
Patients were monitored continuously using bedside monitors or telemetry for the first 16-24 hours after the operation. A 12-lead electrocardiogram (ECG) was obtained at any clinical suspicion of arrhythmia. Atrial tachycardia was defined as a sustained regular monomorphic atrial rhythm at a constant rate >100/min originating outside the sinus node.
Measurement of conduction time On the second postoperative day, the conduction time was measured with the help of pacing the electrode pair on the one side of the cryolesion between the incision and the tricuspid annulus and sensing the unipolar signals on the other side (Figure 2). Signals were recorded at 100 mm/s using a commercially available ECG machine.
Electrophysiology study and coronary angiography Electrophysiology study and coronary angiography were carried out 3 months after the operation. Patients were free of antiarrhythmic agents at the time of the study. Coronary angiography was performed with the usual technique from the femoral approach. Afterwards, a 7-French quadripolar deflectable ablation catheter with a 4-mm tip electrode (Navistar®, Biosense Webster, Diamond Bar, California) was advanced via the right femoral vein into the right atrium for mapping and radiofrequency catheter ablation. An active fixation lead (Sweet Picotip®, Guidant, St. Paul, Minnesota) was screwed in the lateral right atrium near the tricuspid annulus and the performed cryolesion and was used for pacing. Simultaneous recordings of intracardiac electrograms filtered at 50-500 Hz and 12-lead surface ECG were stored digitally (CardioLab®, Prucka Engineering, Inc., Houston, Texas or Prucka CardioLab 2000®, GE Medical Systems, Milwaukee, Wisconsin). An electroanatomic map (CARTO®, Biosense Webster, Diamond Bar, California) was constructed during pacing with special emphasis on the region of surgical scar and cryolesion to be able to judge conduction across the cryolesion. Afterwards, the active fixation lead was repositioned to the opposite side of the cryolesion near the Navistar® catheter, which was placed with the help of the already constructed electroanatomic map. Another electroanatomic map was created under pacing from this second site to judge the completeness of the cryolesion in the other direction. Afterwards, attempts at induction of atrial arrhythmias were made. These included rapid atrial pacing with 20 stimuli starting from a cycle length of 400 ms with 20 ms decrements down to a cycle length of 200 ms, and single and double extrastimuli at 400 ms cycle length down to atrial refractoriness. Isoproterenol was not used during the study.
Safety assessment of the intervention All adverse events were recorded. Likely relationship of adverse events to the study intervention was determined based on the consensus of the participating investigators.
Statistical analysis All calculations were carried out using the statistical software Intercooled Stata® Release 8 (Stata Corporation, College Station, Texas). Comparison of continuous variables was performed using the Student's t-test, or the Wilcoxon rank-sum test, as appropriate. Comparison of proportions was performed using the Fisher's exact test. Median (interquartile range) or mean ± standard deviation are reported, as appropriate.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients operated in the Department of Cardiothoracic Surgery, Aarhus University Hospital at Skejby were included. Inclusion criteria were: 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.
Key exclusion criteria (1 listed)
- Acute operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cryoablation | Procedure or surgery | – |
Primary outcome
Feasibility of creation of a complete line of block
Safety
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lukac, MD principal investigator
Aarhus University Hospital Skejby
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoablation in people with Atrial Tachycardia, run by Aarhus University Hospital Skejby at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of creation of a complete line of block. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2006.