ATRIAL FLUTTERPhase 3FLS-ICE-RNCT02426710
Intracardiac Echocardiography in Atrial Flutter Ablation
A Phase 3 study testing Intracardiac echocardiography in people with ATRIAL FLUTTER, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATRIAL FLUTTER
- What is being tested?
- Intracardiac echocardiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2014to 10 Apr 2017
- Phase
- Phase 3
- 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
- indication for atrial flutter ablation
Who cannot join
- history of recent femoral vein thrombosis (within last 6 months)
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Cardiocenter, 3rd Medical School, Charles University and University Hospital Kralovske Vinohrady
Prague, 10034
About this study
Official title: The Usefulness of Intracardiac Echocardiography in Atrial Flutter Ablation - a Randomized Study
Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear.
Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter.
Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.
Read the detailed description
Introduction Radiofrequency ablation (RFA) of typical atrial flutteru is the most successful method for treatment of atrial flutter. The acute (peri-procedural) efficacy is more than 95%. (1) Typical atrial flutter circuit uses the area between inferior caval vein and tricuspid anulus, so a RFA of typical flutter is performed by providing a linear lesion from inferior caval vein to tricuspid valve (this area is called as cavo-tricuspid isthmus). The recurrence of atrial flutter after ablation, which are caused by non-transmural RF lesion, are in less than 10% of cases. (2) During atrial flutter ablation, typically three electrophysiological catheters are used. Two catheters are diagnostic (one 10-pole inserted into coronary sinus and the other 20-pole inserted in the right atrium with the distal tip laterally from the cavo-ticuspid isthmus). The third is ablation catheter, inserted in the CT isthmus. The location of all three catheters is monitored by fluoroscopy and by the EP signals on catheters. Also the ablation catheter during the ablation is monitored by fluoroscopy and by the signals on the catheter.
Despite its high efficacy, the RFA of atrial flutter can be sometimes very difficult. The most difficulties are done by anatomical differences in patients. (3, 4) In the area of CTI, the rudimentary Eustachian valve can be present, which can hide the effective ablation of the CI tissue. Moreover, deep pouches can be present in the TI area, which, if unrecognized, can present the area of insufficient ablation. Both of them, Eustachian valve or pouches, are not visible by fluoroscopy. In rare cases, a complete block in the CTI are is not achieved, typically due to some anatomical difficulties. Furthermore, this anatomical obstacles can lead to prolonged fluoroscopy time (to find the location of conduction in CTI rea), more RF energy delivery and prolonged procedure time. Longer ablation time increases the risk of ablation (such as right atrial perforation). Next possible anatomical obstacle is the right coronary artery which can effective prevent sufficient ablation due to its cooling effect. (5) Intracardiac echocardiography (ICE) is done by using intracardiac echo probe. The probe is inserted in the right atrium, which allows the visualizing of the CTI area. (6, 7) ICE is used for AF ablation in some centers, but its effect has never been validated in the randomized study. The aim of our study is to assess whether routine use of ICE can lead to decrease fluoroscopy time, decrease need for RFA delivery (i.e. number of ablations) and a decrease procedure time. On the other hand, the safety endpoint will be to assess whether a routine use of ICE is not associated with higher rate of complications. We hypothesize, the use of ICE will shorten fluoroscopy, ablation and procedural time without increased number of complication
Patients and methods:
Consecutive patients indicated due to standard criteria (i.e. according to the guidelines of the European Society of Cardiology) for atrial flutter ablation will be enrolled. Exclusion criterion will be the absence of written informed content and a history of recent femoral vein thrombosis (< 6 months).
Randomization: 1 to 1 for ICE vs. non ICE RF ablation will be done routinely, as it is done in the center. In the Ice group, ICE probe will be inserted through the left femoral vein in the right atrium TH ICE will be used for the visualization of the anatomy of CTI area and the visualization of the catheter during RF delivery. In case of the non-ICE group, RFA will be done without ICE catheter, as it is done routinely now. In both groups, the diagnostic catheters (10-pole CS and 20-po in the RA) and ablation catheter will be the same. In the non-ICE group, the location of the catheters will be assessed by fluoroscopy and by signals on catheters. At the end of ablation, total fluoroscopy time, the number and length of ablation and the duration of procedure will be calculated. On the day and two weeks after the procedure, the bleeding complication will be assessed.
End-points: the major end-points will be: 1) total procedure duration (min) 2) fluoroscopy time 3) the number of ablations 4) the total duration of RF energy delivery. Major safety end-point will be complication from left femoral ICE access.
- Conditions
- ATRIAL FLUTTER
- Being tested
- Intracardiac echocardiography
- Keywords
- ablation, atrial flutter, intracardiac echocardiography
- Medical subject headings
- Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac echocardiographyDevice
Flutter ablation will be done using intracardiac echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Flutter ablation with intracardiac echocardiography | Experimental | Atrial flutter ablation will be done using intracardiac echocardiography. Receives: Device: Intracardiac echocardiography |
| Flutter ablation without intracardiac echocardiography | Active comparator | Atrial flutter ablation will be done without intracardiac echocardiography. Receives: Device: Intracardiac echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
The total lenght of the procedure in minuts will be measured.
Measured: intraoperative
Fluoroscopy time during ablation
The total fluoroscopy time will be measured.
Measured: intraoperative
Total ablation time
The time of radiofrequenc energy delivery during ablation will me measured.
Measured: intraoperative
Bleeding
The bleeding complication required intervention or prolonged hospitalization will be measured.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJun 2014
- Primary completion10 Apr 2017
- Study completion10 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ATRIAL FLUTTERStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RAndomization to ICE or no ICE
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pavel Osmancik, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426710
- Sponsor's protocol ID
- FLS-ICE randomized
- Acronym
- FLS-ICE-R
- Status last verified
- Jan 2019
- First submitted
- 22 Apr 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Study was published
Publications
Scaglione M, Caponi D, Di Donna P, Riccardi R, Bocchiardo M, Azzaro G, Leuzzi S, Gaita F. Typical atrial flutter ablation outcome: correlation with isthmus anatomy using intracardiac echo 3D reconstruction. Europace. 2004 Sep;6(5):407-17. doi: 10.1016/j.eupc.2004.05.008.
PubMed 15294265Lee G, Sanders P, Kalman JM. Catheter ablation of atrial arrhythmias: state of the art. Lancet. 2012 Oct 27;380(9852):1509-19. doi: 10.1016/S0140-6736(12)61463-9.
PubMed 23101718Schumacher B, Pfeiffer D, Tebbenjohanns J, Lewalter T, Jung W, Luderitz B. Acute and long-term effects of consecutive radiofrequency applications on conduction properties of the subeustachian isthmus in type I atrial flutter. J Cardiovasc Electrophysiol. 1998 Feb;9(2):152-63. doi: 10.1111/j.1540-8167.1998.tb00896.x.
PubMed 9511889Gami AS, Edwards WD, Lachman N, Friedman PA, Talreja D, Munger TM, Hammill SC, Packer DL, Asirvatham SJ. Electrophysiological anatomy of typical atrial flutter: the posterior boundary and causes for difficulty with ablation. J Cardiovasc Electrophysiol. 2010 Feb;21(2):144-9. doi: 10.1111/j.1540-8167.2009.01607.x. Epub 2009 Oct 5.
PubMed 19804553Lai LP, Lin JL, Lin JM, Du CC, Tseng YZ, Huang SK. Use of double-potential barrier to identify functional isthmus at the cavotricuspid isthmus for facilitating catheter ablation of isthmus-dependent atrial flutter. J Cardiovasc Electrophysiol. 2004 Apr;15(4):396-401. doi: 10.1046/j.1540-8167.2004.03424.x.
PubMed 15089986Al Aloul B, Sigurdsson G, Can I, Li JM, Dykoski R, Tholakanahalli VN. Proximity of right coronary artery to cavotricuspid isthmus as determined by computed tomography. Pacing Clin Electrophysiol. 2010 Nov;33(11):1319-23. doi: 10.1111/j.1540-8159.2010.02844.x.
PubMed 20663073Morton JB, Sanders P, Davidson NC, Sparks PB, Vohra JK, Kalman JM. Phased-array intracardiac echocardiography for defining cavotricuspid isthmus anatomy during radiofrequency ablation of typical atrial flutter. J Cardiovasc Electrophysiol. 2003 Jun;14(6):591-7. doi: 10.1046/j.1540-8167.2003.02152.x.
PubMed 12875419
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Intracardiac Echocardiography in Atrial Flutter Ablation - a Randomized Study
- ClinicalTrials.gov ID
- NCT02426710
- Acronym / sponsor ID
- FLS-ICE-R / FLS-ICE randomized
- Conditions
- ATRIAL FLUTTER
- Keywords
- ablation, atrial flutter, intracardiac echocardiography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- 10 Apr 2017 (actual)
- Study completion
- 10 Apr 2017 (actual)
- First posted
- 27 Apr 2015 (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.
Background: Radiofrequency ablation of typical atrial flutter present the most effective treament option in treatment of atrial flutter. Despite its high efficacy, due tovariant anatomy of cavotricuspid isthmus (CTI), i.e. location of right coronary artery, pouches, the achievment of complete bidirectional block across the CTI is sometimes chalenging. Intracardiac echocardiography (ICE) is a very usefull tool for on-line vizualization of the anatomy of the atria and also for the location of catheter position on CTI during ablation. If the routine use of ICE is associated with easier atrial fluter ablation is not clear.
Methods: One hundred consecutive patients indicated for typical atrial flutter ablation will be enrolled into the study. The patients will be randomized into group (A) ablation with use of ICE and (B) ablation without ICE. The ablation will be done in both groups by two diagnostic catheters (10-pole positioned in coronary sinus and 20-pole halo catheter positioned in the right atrium) and radiofrequency ablation catheter. The end-point of the ablation is the achievment of the bicidrectional block across the CTI. The end-points of the study are 1) the total length of the procedure, 2) the fluoroscopy time and 3) the ablation time. The safety end-point is clinically significant bleeding from the groin due to additional puncture for ICE catheter.
Discussion: We hypothesize the use of ICE wil shorten the radiofrequency energy delivery, fluoroscopy time and the length of the procedure without increasing the bleeding.
Detailed description
Introduction Radiofrequency ablation (RFA) of typical atrial flutteru is the most successful method for treatment of atrial flutter. The acute (peri-procedural) efficacy is more than 95%. (1) Typical atrial flutter circuit uses the area between inferior caval vein and tricuspid anulus, so a RFA of typical flutter is performed by providing a linear lesion from inferior caval vein to tricuspid valve (this area is called as cavo-tricuspid isthmus). The recurrence of atrial flutter after ablation, which are caused by non-transmural RF lesion, are in less than 10% of cases. (2) During atrial flutter ablation, typically three electrophysiological catheters are used. Two catheters are diagnostic (one 10-pole inserted into coronary sinus and the other 20-pole inserted in the right atrium with the distal tip laterally from the cavo-ticuspid isthmus). The third is ablation catheter, inserted in the CT isthmus. The location of all three catheters is monitored by fluoroscopy and by the EP signals on catheters. Also the ablation catheter during the ablation is monitored by fluoroscopy and by the signals on the catheter.
Despite its high efficacy, the RFA of atrial flutter can be sometimes very difficult. The most difficulties are done by anatomical differences in patients. (3, 4) In the area of CTI, the rudimentary Eustachian valve can be present, which can hide the effective ablation of the CI tissue. Moreover, deep pouches can be present in the TI area, which, if unrecognized, can present the area of insufficient ablation. Both of them, Eustachian valve or pouches, are not visible by fluoroscopy. In rare cases, a complete block in the CTI are is not achieved, typically due to some anatomical difficulties. Furthermore, this anatomical obstacles can lead to prolonged fluoroscopy time (to find the location of conduction in CTI rea), more RF energy delivery and prolonged procedure time. Longer ablation time increases the risk of ablation (such as right atrial perforation). Next possible anatomical obstacle is the right coronary artery which can effective prevent sufficient ablation due to its cooling effect. (5) Intracardiac echocardiography (ICE) is done by using intracardiac echo probe. The probe is inserted in the right atrium, which allows the visualizing of the CTI area. (6, 7) ICE is used for AF ablation in some centers, but its effect has never been validated in the randomized study. The aim of our study is to assess whether routine use of ICE can lead to decrease fluoroscopy time, decrease need for RFA delivery (i.e. number of ablations) and a decrease procedure time. On the other hand, the safety endpoint will be to assess whether a routine use of ICE is not associated with higher rate of complications. We hypothesize, the use of ICE will shorten fluoroscopy, ablation and procedural time without increased number of complication
Patients and methods:
Consecutive patients indicated due to standard criteria (i.e. according to the guidelines of the European Society of Cardiology) for atrial flutter ablation will be enrolled. Exclusion criterion will be the absence of written informed content and a history of recent femoral vein thrombosis (< 6 months).
Randomization: 1 to 1 for ICE vs. non ICE RF ablation will be done routinely, as it is done in the center. In the Ice group, ICE probe will be inserted through the left femoral vein in the right atrium TH ICE will be used for the visualization of the anatomy of CTI area and the visualization of the catheter during RF delivery. In case of the non-ICE group, RFA will be done without ICE catheter, as it is done routinely now. In both groups, the diagnostic catheters (10-pole CS and 20-po in the RA) and ablation catheter will be the same. In the non-ICE group, the location of the catheters will be assessed by fluoroscopy and by signals on catheters. At the end of ablation, total fluoroscopy time, the number and length of ablation and the duration of procedure will be calculated. On the day and two weeks after the procedure, the bleeding complication will be assessed.
End-points: the major end-points will be: 1) total procedure duration (min) 2) fluoroscopy time 3) the number of ablations 4) the total duration of RF energy delivery. Major safety end-point will be complication from left femoral ICE access.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RAndomization to ICE or no ICE
| Arm | Type | Receives |
|---|---|---|
| Flutter ablation with intracardiac echocardiography | Experimental | Device: Intracardiac echocardiographyAtrial flutter ablation will be done using intracardiac echocardiography. |
| Flutter ablation without intracardiac echocardiography | Active comparator | Device: Intracardiac echocardiographyAtrial flutter ablation will be done without intracardiac echocardiography. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- indication for atrial flutter ablation
Key exclusion criteria (1 listed)
- history of recent femoral vein thrombosis (within last 6 months)
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 |
|---|---|---|
| Intracardiac echocardiographyFlutter ablation will be done using intracardiac echocardiography. | Device | Flutter ablation with intracardiac echocardiography, Flutter ablation without intracardiac echocardiography |
Primary outcome
Procedure duration
Time frame: intraoperative
The total lenght of the procedure in minuts will be measured.
Fluoroscopy time during ablation
Time frame: intraoperative
The total fluoroscopy time will be measured.
Total ablation time
Time frame: intraoperative
The time of radiofrequenc energy delivery during ablation will me measured.
Bleeding
Time frame: 24 hours
The bleeding complication required intervention or prolonged hospitalization will be measured.
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 31 Jan 2019.
- Background: PubMed 15294265Scaglione M, Caponi D, Di Donna P, Riccardi R, Bocchiardo M, Azzaro G, Leuzzi S, Gaita F. Typical atrial flutter ablation outcome: correlation with isthmus anatomy using intracardiac echo 3D reconstruction. Europace. 2004 Sep;6(5):407-17. doi: 10.1016/j.eupc.2004.05.008.
- Results publication: PubMed 23101718Lee G, Sanders P, Kalman JM. Catheter ablation of atrial arrhythmias: state of the art. Lancet. 2012 Oct 27;380(9852):1509-19. doi: 10.1016/S0140-6736(12)61463-9.
- Results publication: PubMed 9511889Schumacher B, Pfeiffer D, Tebbenjohanns J, Lewalter T, Jung W, Luderitz B. Acute and long-term effects of consecutive radiofrequency applications on conduction properties of the subeustachian isthmus in type I atrial flutter. J Cardiovasc Electrophysiol. 1998 Feb;9(2):152-63. doi: 10.1111/j.1540-8167.1998.tb00896.x.
- Results publication: PubMed 19804553Gami AS, Edwards WD, Lachman N, Friedman PA, Talreja D, Munger TM, Hammill SC, Packer DL, Asirvatham SJ. Electrophysiological anatomy of typical atrial flutter: the posterior boundary and causes for difficulty with ablation. J Cardiovasc Electrophysiol. 2010 Feb;21(2):144-9. doi: 10.1111/j.1540-8167.2009.01607.x. Epub 2009 Oct 5.
- Results publication: PubMed 15089986Lai LP, Lin JL, Lin JM, Du CC, Tseng YZ, Huang SK. Use of double-potential barrier to identify functional isthmus at the cavotricuspid isthmus for facilitating catheter ablation of isthmus-dependent atrial flutter. J Cardiovasc Electrophysiol. 2004 Apr;15(4):396-401. doi: 10.1046/j.1540-8167.2004.03424.x.
- Results publication: PubMed 20663073Al Aloul B, Sigurdsson G, Can I, Li JM, Dykoski R, Tholakanahalli VN. Proximity of right coronary artery to cavotricuspid isthmus as determined by computed tomography. Pacing Clin Electrophysiol. 2010 Nov;33(11):1319-23. doi: 10.1111/j.1540-8159.2010.02844.x.
- Results publication: PubMed 12875419Morton JB, Sanders P, Davidson NC, Sparks PB, Vohra JK, Kalman JM. Phased-array intracardiac echocardiography for defining cavotricuspid isthmus anatomy during radiofrequency ablation of typical atrial flutter. J Cardiovasc Electrophysiol. 2003 Jun;14(6):591-7. doi: 10.1046/j.1540-8167.2003.02152.x.
- Individual participant dataSharing planned: No. Study was published
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intracardiac echocardiography in people with ATRIAL FLUTTER, run by Charles University, Czech Republic at 1 site in Czechia.
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 31 Jan 2019. 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 Czechia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Procedure duration (time frame: intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02426710, which also lists 7 linked publications.
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 31 Jan 2019.