Atrial FibrillationCATAFABLNCT00816192
Comparison of Externally Versus Internally Cooled Tip Catheter Ablation in Paroxysmal Atrial Fibrillation
A study testing Long-term electrical isolation of pulmonary veins in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 2 sites in France.
Trial summary
There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF). The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long… 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?
- Long-term electrical isolation of pulmonary veins
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 2 sitesFrance
- Study dates
- Dec 2008to Mar 2011
- 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
- Adults (≥18 years old)
- Drug refractory paroxysmal AF with episods lasting <24hours
- Follow-up possible at one of the 2 institutions performing the study
- Oral agreement of the patient after reading the document of information
Who cannot join
- Pregnancy
- Psychiatric troubles not stabilized
- Contraindication to undergo AF ablation
- Previous attempt at AF ablation
- Cardioversion for AF
- No oral agreement of the patient for the study
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital
Bordeaux, 33064
Clinique Pasteur
Toulouse, 31076
About this study
Official title: Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation
There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).
The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).
Read the detailed description
Atrial fibrillation is the most common of all sustained cardiac arrhythmias, with the prevalence increasing with age to up to 5 percent in persons more than 65 years of age, to 10 percent in persons more than 80 years of age and it is a major cause of stroke.
Since its introduction into clinical practice, catheter ablation (CA) aimed at cure of atrial fibrillation (AF) has become increasingly prevalent. Different techniques have been proposed and are currently under investigation in various electrophysiology (EP) laboratories, with increasing knowledge of the pathophysiology of human AF and critical assessment of clinical outcome after the curative procedure. The favorable results reported in different studies have fueled enthusiasm for CA of AF, with the number of ablation procedures increasing from 1994 to the present time. However, these technologies have varied catheter designs, ranging from different forms of irrigation (external or internal irrigation). The increase of the rate of success of the AF by ablation with the development of new catheters has permitted a considerable reduction of the medical treatment and the disappearance of grave complications. The procedure will be " standard " with isolation of pulmonary veins and block through the cavo-tricuspid isthmus obtained.
Following completion of the procedure, patients will have anti vitamin K drug therapy for 3 months and antiarrhythmic drug for 1 month in case of early atrial arrhythmia recurrence. Two-dimensional echocardiogram will be performed systematically prior to discharge. All 3 months, long-term follow-up consisted from the date of the ablation procedure with consultation, stress test, holter-ECG (24 h) and echocardiography. At 3 months a repeat EP procedure will be performed in patients with AF recurrence to assess whether or not lines are still blocked. If not, RF will be delivered to block them again and cure AF.
- Conditions
- Atrial Fibrillation
- Being tested
- Long-term electrical isolation of pulmonary veins
- Keywords
- FA, Atrial fibrillation, Catheter, Ablation, RF
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term electrical isolation of pulmonary veinsProcedure or surgery
All AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | The externally irrigated-tip catheter is an "open system" in which saline is continuously infused and empties into the blood pool. For the externally irrigated-tip catheter, RF energy delivery settings were: power ≤ 35 watts and temperature ≤ 43°C with a variable flow-rate to obtain a temperature around 40°C. Receives: Procedure: Long-term electrical isolation of pulmonary veins |
| 2 | Experimental | For the internally irrigated tip catheter (reference catheter), radiofrequency (RF) energy delivery settings will be: power ≤ 35 watts, temperature ≤ 47◦C and a fixed flow rate of 0.6 ml/s.
The advantage of the Chili thermo-cooled tip system is that no saline solution leaves the catheter system and flows into the patient. Receives: Procedure: Long-term electrical isolation of pulmonary veins |
What is being measured
The primary outcome is the main question the study is designed to answer.
RF duration (in minutes) to succeed in PVs isolation
Measured: Along intervention
Secondary outcomes (2)
The absence of pAF
Measured: at 3 and 6 months off AAD
The determination of serious adverse events (Complications resulting from vascular access will not be included in this category).
Measured: During 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: The production of the device used in this study has been suspended.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Michel HAÏSSAGUERRE, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816192
- Sponsor's protocol ID
- CHUBX 2008/27
- Acronym
- CATAFABL
- Status last verified
- Jul 2012
- First submitted
- 30 Dec 2008
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Externally Versus Internally Cooled Tip Catheter in Achieving Long-term Electrical Isolation of Pulmonary Veins in Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00816192
- Acronym / sponsor ID
- CATAFABL / CHUBX 2008/27
- Conditions
- Atrial Fibrillation
- Keywords
- FA, Atrial fibrillation, Catheter, Ablation, RF
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The production of the device used in this study has been suspended.
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 31 Dec 2008 (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.
There is no study comparing safety/efficacy of externally vs internally cooled tip catheters in patients undergoing ablation for paroxysmal atrial fibrillation (pAF).
The primary objective is to compare safety and efficacy of externally irrigated-tip catheter versus internally irrigated-tip catheter in achieving long term electrical isolation (EI) of pulmonary veins (PV) in paroxysmalatrial fibrillation (pAF).
Detailed description
Atrial fibrillation is the most common of all sustained cardiac arrhythmias, with the prevalence increasing with age to up to 5 percent in persons more than 65 years of age, to 10 percent in persons more than 80 years of age and it is a major cause of stroke.
Since its introduction into clinical practice, catheter ablation (CA) aimed at cure of atrial fibrillation (AF) has become increasingly prevalent. Different techniques have been proposed and are currently under investigation in various electrophysiology (EP) laboratories, with increasing knowledge of the pathophysiology of human AF and critical assessment of clinical outcome after the curative procedure. The favorable results reported in different studies have fueled enthusiasm for CA of AF, with the number of ablation procedures increasing from 1994 to the present time. However, these technologies have varied catheter designs, ranging from different forms of irrigation (external or internal irrigation). The increase of the rate of success of the AF by ablation with the development of new catheters has permitted a considerable reduction of the medical treatment and the disappearance of grave complications. The procedure will be " standard " with isolation of pulmonary veins and block through the cavo-tricuspid isthmus obtained.
Following completion of the procedure, patients will have anti vitamin K drug therapy for 3 months and antiarrhythmic drug for 1 month in case of early atrial arrhythmia recurrence. Two-dimensional echocardiogram will be performed systematically prior to discharge. All 3 months, long-term follow-up consisted from the date of the ablation procedure with consultation, stress test, holter-ECG (24 h) and echocardiography. At 3 months a repeat EP procedure will be performed in patients with AF recurrence to assess whether or not lines are still blocked. If not, RF will be delivered to block them again and cure AF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Long-term electrical isolation of pulmonary veinsThe externally irrigated-tip catheter is an "open system" in which saline is continuously infused and empties into the blood pool. For the externally irrigated-tip catheter, RF energy delivery settings were: power ≤ 35 watts and temperature ≤ 43°C with a variable flow-rate to obtain a temperature around 40°C. |
| 2 | Experimental | Procedure: Long-term electrical isolation of pulmonary veinsFor the internally irrigated tip catheter (reference catheter), radiofrequency (RF) energy delivery settings will be: power ≤ 35 watts, temperature ≤ 47◦C and a fixed flow rate of 0.6 ml/s. The advantage of the Chili thermo-cooled tip system is that no saline solution leaves the catheter system and flows into the patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults (≥18 years old)
- Drug refractory paroxysmal AF with episods lasting <24hours
- Follow-up possible at one of the 2 institutions performing the study
- Oral agreement of the patient after reading the document of information
Key exclusion criteria (6 listed)
- Pregnancy
- Psychiatric troubles not stabilized
- Contraindication to undergo AF ablation
- Previous attempt at AF ablation
- Cardioversion for AF
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 |
|---|---|---|
| Long-term electrical isolation of pulmonary veinsAll AAD except amiodarone will be stopped five half-lives before the procedure. Our ablation protocol will require 3 catheters. A quadripolar stearable mapping catheter was inserted into the coronary sinus, a decapolar circular mapping catheter was placed at the antrum of the PV after transeptal puncture to help for electrical disconnection of all four PV with the randomized ablation catheter. After transseptal access, an intravenous bolus of heparin was administered and repeated 3 to 4 hours later. Atrial burst will then be used to induce AF. With the ablation catheter positioned proximal to Lasso catheter on the atrial aspect of PV ostium, isolation will be performed. | Procedure or surgery | 1, 2 |
Primary outcome
RF duration (in minutes) to succeed in PVs isolation
Time frame: Along intervention
2 secondary outcomes
The absence of pAF
Time frame: at 3 and 6 months off AAD
The determination of serious adverse events (Complications resulting from vascular access will not be included in this category).
Time frame: During 6 months
Results and safety
The study was stopped early (reason given: The production of the device used in this study has been suspended.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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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.
Michel HAÏSSAGUERRE, Pr principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long-term electrical isolation of pulmonary veins in people with Atrial Fibrillation, run by University Hospital, Bordeaux at 2 sites in France.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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 was stopped early (reason given: The production of the device used in this study has been suspended.). Results are not available in the source record.
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?
RF duration (in minutes) to succeed in PVs isolation (time frame: Along intervention). 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 27 Jul 2012.