Atrial FibrillationEVACIRCNCT02107027
Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
A study testing nMARQ catheter and Navistar catheter in people with Atrial Fibrillation, run by Association de Recherche pour le Traitement des Arythmies Cardiaques at 1 site in France.
Trial summary
The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation. Currently, two technologies of irrigated ablation catheters are available for PVI. 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?
- nMARQ catheter and Navistar catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2013to Sep 2018
- 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
- Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
- Age superior or equal to 18 years old, both genders.
- Patient's oral agreement for study participation after reading information note.
- Patient affiliated or recipient of a social welfare regimen.
Who cannot join
- Age inferior to 18 years old
- Pregnancy
- Unbalanced psychiatric disorders
- Contraindication to atrial fibrillation ablation by endocardial way.
- Redo-ablation
- No patient's oral agreement for study participation
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.
Currently, two technologies of irrigated ablation catheters are available for PVI.
Read more
One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.
The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.
These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.
- Conditions
- Atrial Fibrillation
- Being tested
- nMARQ catheter, Navistar catheter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nMARQ catheterDevice
In this arm the circular ablation catheter will be used for a quick mapping of left atrium with Carto system. The catheter will be positioned to pulmonary veins ostium to deliver radiofrequency on 1 to 10 electrodes simultaneous. The same catheter will be used to document pulmonary veins isolation (PVI).
A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) site(s) will be noted.
Navistar catheterDevice
In this arm the conventional catheter will be used. It will be used for a left atrium quick mapping on Carto system. Radiofrequency will be delivered in a sequential manner in pulmonary veins for point by point ablation. Isolation will be guided and confirmed with the Lasso decapolar diagnostic catheter (Biosense Webster, Diamond Bar, USA).
A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) sites will be noted.
| Study group | Role | What they receive |
|---|---|---|
| nMARQ catheter (circular catheter) | Active comparator | Group treated with the circular ablation catheter for atrial fibrillation ablation Receives: Device: nMARQ catheter |
| Navistar catheter (conventional catheter) | Active comparator | Group treated with the conventional ablation catheter for atrial fibrillation ablation Receives: Device: Navistar catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Pulmonary veins reconnection
Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)
Measured: End of ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2014 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionSep 2018 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association de Recherche pour le Traitement des Arythmies Cardiaques
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre JAIS, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02107027
- Sponsor's protocol ID
- EVACIRC
- Acronym
- EVACIRC
- Status last verified
- Jun 2017
- First submitted
- 31 Mar 2014
- Last updated
- 2 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Veins Circular Ablation Catheter Evaluation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02107027
- Acronym / sponsor ID
- EVACIRC / EVACIRC
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Association de Recherche pour le Traitement des Arythmies CardiaquesUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 8 Apr 2014 (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.
The aim of this study is to compare two type of ablation catheters for pulmonary veins isolation (PVI) in subjects with atrial fibrillation.
Currently, two technologies of irrigated ablation catheters are available for PVI.
One of the two, the "conventional" catheter is widely used for atrial fibrillation (AF) treatment but has not been specifically created for pulmonary veins isolation, therefore, point by point encircling lesions are cumbersome and time consuming.
The second is a new ablation catheter with a circular shape provided with 10 irrigated electrodes designed to create encircling lesions, necessary to obtain pulmonary veins isolation, could allow an easier and faster isolation compared to the conventional way.
These two types of catheters have never been compared for atrial fibrillation. If one of the two catheters appears to be more efficient or causes fewer complications, the use of this catheter could be favored to conduct AF ablation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nMARQ catheter (circular catheter) | Active comparator | Device: nMARQ catheterGroup treated with the circular ablation catheter for atrial fibrillation ablation |
| Navistar catheter (conventional catheter) | Active comparator | Device: Navistar catheterGroup treated with the conventional ablation catheter for atrial fibrillation ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject with atrial fibrillation refractory to anti-arrhythmic drugs, with episodes lasting less than 7 days and eligible for atrial fibrillation ablation.
- Age superior or equal to 18 years old, both genders.
- Patient's oral agreement for study participation after reading information note.
- Patient affiliated or recipient of a social welfare regimen.
Key exclusion criteria (6 listed)
- Age inferior to 18 years old
- Pregnancy
- Unbalanced psychiatric disorders
- Contraindication to atrial fibrillation ablation by endocardial way.
- Redo-ablation
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 |
|---|---|---|
| nMARQ catheterIn this arm the circular ablation catheter will be used for a quick mapping of left atrium with Carto system. The catheter will be positioned to pulmonary veins ostium to deliver radiofrequency on 1 to 10 electrodes simultaneous. The same catheter will be used to document pulmonary veins isolation (PVI). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) site(s) will be noted. | Device | nMARQ catheter (circular catheter) |
| Navistar catheterIn this arm the conventional catheter will be used. It will be used for a left atrium quick mapping on Carto system. Radiofrequency will be delivered in a sequential manner in pulmonary veins for point by point ablation. Isolation will be guided and confirmed with the Lasso decapolar diagnostic catheter (Biosense Webster, Diamond Bar, USA). A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) sites will be noted. | Device | Navistar catheter (conventional catheter) |
Primary outcome
Number of Pulmonary veins reconnection
Time frame: End of ablation procedure
Number of Pulmonary veins reconnection 30 minutes after the isolation in each group + ATP injection (number between 0 and 4)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
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.
Pierre JAIS, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nMARQ catheter and Navistar catheter in people with Atrial Fibrillation, run by Association de Recherche pour le Traitement des Arythmies Cardiaques at 1 site 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: status not confirmed, as of the sponsor's last update on 2 Jul 2017. 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 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?
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?
Number of Pulmonary veins reconnection (time frame: End of ablation procedure). 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 2 Jul 2017.