Atrial FibrillationCE-AFNCT01361295
Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF)
A study testing PVI with PVAC gold and PVI with Cooled-RF in people with Atrial Fibrillation, run by Serge A. Trines at 1 site in Netherlands.
Trial summary
Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVI with PVAC gold and PVI with Cooled-RF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2015to Dec 2017
- 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
- suffering from drug-refractory paroxysmal atrial fibrillation
- scheduled for first ablation procedure
Who cannot join
- contra-indications for DW-MRI
- previous AF-ablation
- minors
- any patient unable to undergo neuropsychological testing due to mental retardation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters
Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.
Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.
Read more
The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.
Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.
Read the detailed description
A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.
Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.
Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.
Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).
- Conditions
- Atrial Fibrillation
- Being tested
- PVI with PVAC gold, PVI with Cooled-RF
- Keywords
- Atrial fibrillation, cerebral embolism, catheter ablation
- Medical subject headings
- Atrial Fibrillation, Intracranial Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVI with PVAC goldProcedure or surgery
Also called Medtronic AF solutions
Pulmonary vein isolation using the Medtronic PVAC gold catheter
PVI with Cooled-RFProcedure or surgery
Also called CARTO3 system
Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
| Study group | Role | What they receive |
|---|---|---|
| PVI with PVAC gold | Active comparator | Patient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention. Receives: Procedure: PVI with Cooled-RF |
| PVI with Cooled-RF | Active comparator | Patient for pulmonal vein isolation using the Cooled-RF catheter. Receives: Procedure: PVI with PVAC gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral embolism
Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.
Measured: Between 24 hours before the ablation and 24 hours after the ablation
Secondary outcomes (2)
Neuropsychological functioning
A decrease in neuropsychological functioning will be assessed with a questionnaire before and after the procedure
Measured: Between a week before the ablation until 3 months after the ablation
Rise in procoagulation
The procoagulant state will be assessed before, during and after the procedure by measurement of markers of endothelial damage, markers of activated coagulation, markers of fibrinolysis and by measurement of APTT, PT-INR, fibrinogen and thrombin generation.
Measured: Between 24 hours before the ablation and 24 hours after the ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startMar 2015
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serge A. Trines
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serge A. Trines, Leiden University Medical Center
- Investigators
- Serge A. Trines, MD, PhD, Principal investigator, Cardiology, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361295
- Sponsor's protocol ID
- CE-AF-002
- Acronym
- CE-AF
- Status last verified
- Sep 2020
- First submitted
- 20 May 2011
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sauren LD, VAN Belle Y, DE Roy L, Pison L, LA Meir M, VAN DER Veen FH, Crijns HJ, Jordaens L, Mess WH, Maessen JG. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1102-7. doi: 10.1111/j.1540-8167.2009.01509.x. Epub 2009 Jun 22.
PubMed 19549035Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nahle CP, Schwab JO, Linhart M, Andrie R, Nickenig G, Sommer T. Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation. Europace. 2010 Jan;12(1):52-7. doi: 10.1093/europace/eup350.
PubMed 19933517Bulava A, Slavik L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcova V, Indrak K. Endothelial damage and activation of the hemostatic system during radiofrequency catheter isolation of pulmonary veins. J Interv Card Electrophysiol. 2004 Jun;10(3):271-9. doi: 10.1023/B:JICE.0000026924.96281.be.
PubMed 15133367Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, Brugman JA, Rooijmans AM, van Buchem MA, Middelkoop HA, Eikenboom J, Schalij MJ, Zeppenfeld K, Trines SA. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2019 Mar;5(3):318-326. doi: 10.1016/j.jacep.2018.11.008. Epub 2018 Dec 26.
PubMed 30898234
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Occurrence of Cerebral Embolism (CE) in Catheter Ablation of Atrial Fibrillation (AF) Using Two Different Ablation Catheters
- ClinicalTrials.gov ID
- NCT01361295
- Acronym / sponsor ID
- CE-AF / CE-AF-002
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, cerebral embolism, catheter ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Serge A. TrinesUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 May 2011 (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.
Radiofrequency catheter ablation of atrial fibrillation (AF) induces a procoagulant state, which leads to an acute risk for symptomatic cerebral embolism (CE) of approximately 1%. The induction of a procoagulant state has been studied in pulmonary vein isolation (PVI) with a non-cooled tip catheter. The induction of a procoagulant state using a cooled-tip catheter has not been studied yet. Due to the avoidance of high endocardial temperatures, it can be expected that these procedures induce a lower level of procoagulation.
Recent studies showed an 11% incidence of CE on diffusion weighted (DW) MRI in patients undergoing cooled-tip catheter ablation of AF. In this study there will be used to different catheters, the cooled-tip catheter and the PVAC Gold catheter. Since the PVAC Gold catheter is equipped with non-cooled electrodes, the risk of endothelial scarring, local thrombosis and CE may be increased.
The goal of this study is to determine the effect of two different ablation catheters on the induction of a procoagulant state and the incidence of CE on DW-MRI in patients with AF undergoing PVI.
Our hypothesis is that patients with AF undergoing PVI using the PVAC gold catheter will show a higher rise in procoagulation and a higher incidence of CE on DW-MRI than patients with AF undergoing PVI with the cooled-tip catheter.
Detailed description
A total of 70 patients scheduled for a first ablation of paroxysmal AF will be included. Patients will be 1:1 randomized to PVI using the PVAC gold catheter or the cooled-tip catheter. A control group of 20 patients with AF but without undergoing ablation is included for neuropsychological testing.
Before the procedure, the procoagulant state will be assessed by measuring several markers of endothelial damage, activated coagulation, fibrinolysis and by measurement of fibrinogen and thrombin generation. Measurements will be repeated during and after the procedure.
Documentation of the formation of CE will be established by performing a DW-MRI before and after the ablation. The proportion of symptomatic CE will be quantified by neuropsychological tests and questionnaires.
Finally, transcranial doppler will be performed during the entire procedure to quantify the number and pattern of cerebral microembolic signals (MES).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PVI with PVAC gold | Active comparator | Procedure: PVI with Cooled-RFPatient for pulmonal vein isolation using the PVAC Gold Catheter. Intervention. |
| PVI with Cooled-RF | Active comparator | Procedure: PVI with PVAC goldPatient for pulmonal vein isolation using the Cooled-RF catheter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suffering from drug-refractory paroxysmal atrial fibrillation
- scheduled for first ablation procedure
Key exclusion criteria (4 listed)
- contra-indications for DW-MRI
- previous AF-ablation
- minors
- any patient unable to undergo neuropsychological testing due to mental retardation
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 |
|---|---|---|
| PVI with PVAC goldAlso: Medtronic AF solutionsPulmonary vein isolation using the Medtronic PVAC gold catheter | Procedure or surgery | PVI with Cooled-RF |
| PVI with Cooled-RFAlso: CARTO3 systemPulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter | Procedure or surgery | PVI with PVAC gold |
Primary outcome
Cerebral embolism
Time frame: Between 24 hours before the ablation and 24 hours after the ablation
Cerebral embolism will be documented with diffusion weighted MRI of the brain before and after ablation.
2 secondary outcomes
Neuropsychological functioning
Time frame: Between a week before the ablation until 3 months after the ablation
Rise in procoagulation
Time frame: Between 24 hours before the ablation and 24 hours after the ablation
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 2 Sep 2020.
- Background: PubMed 19549035Sauren LD, VAN Belle Y, DE Roy L, Pison L, LA Meir M, VAN DER Veen FH, Crijns HJ, Jordaens L, Mess WH, Maessen JG. Transcranial measurement of cerebral microembolic signals during endocardial pulmonary vein isolation: comparison of three different ablation techniques. J Cardiovasc Electrophysiol. 2009 Oct;20(10):1102-7. doi: 10.1111/j.1540-8167.2009.01509.x. Epub 2009 Jun 22.
- Background: PubMed 19933517Schrickel JW, Lickfett L, Lewalter T, Mittman-Braun E, Selbach S, Strach K, Nahle CP, Schwab JO, Linhart M, Andrie R, Nickenig G, Sommer T. Incidence and predictors of silent cerebral embolism during pulmonary vein catheter ablation for atrial fibrillation. Europace. 2010 Jan;12(1):52-7. doi: 10.1093/europace/eup350.
- Background: PubMed 15133367Bulava A, Slavik L, Fiala M, Heinc P, Skvarilova M, Lukl J, Krcova V, Indrak K. Endothelial damage and activation of the hemostatic system during radiofrequency catheter isolation of pulmonary veins. J Interv Card Electrophysiol. 2004 Jun;10(3):271-9. doi: 10.1023/B:JICE.0000026924.96281.be.
- Derived from this study: PubMed 30898234Kece F, Bruggemans EF, de Riva M, Alizadeh Dehnavi R, Wijnmaalen AP, Meulman TJ, Brugman JA, Rooijmans AM, van Buchem MA, Middelkoop HA, Eikenboom J, Schalij MJ, Zeppenfeld K, Trines SA. Incidence and Clinical Significance of Cerebral Embolism During Atrial Fibrillation Ablation With Duty-Cycled Phased-Radiofrequency Versus Cooled-Radiofrequency: A Randomized Controlled Trial. JACC Clin Electrophysiol. 2019 Mar;5(3):318-326. doi: 10.1016/j.jacep.2018.11.008. Epub 2018 Dec 26.
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Atrial Fibrillation (AF)
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.
Serge A. Trines, MD, PhD principal investigator
Cardiology, LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVI with PVAC gold and PVI with Cooled-RF in people with Atrial Fibrillation, run by Serge A. Trines at 1 site in Netherlands.
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 2 inclusion and 4 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 2 Sep 2020. 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 Netherlands. 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?
Cerebral embolism (time frame: Between 24 hours before the ablation and 24 hours after the ablation). 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 NCT01361295, which also lists 4 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 2 Sep 2020.