Paroxysmal Atrial FibrillationNCT01630031
Contact Force Sensing and Pulmonary Vein Isolation
An observational study of Paroxysmal Atrial Fibrillation and Catheter Ablation, run by Clinique Pasteur at 1 site in France.
Trial summary
Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Catheter Ablation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2010to Nov 2012
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population included patients with paroxysmal atrial fibrillation who undergo a first catheter ablation procedure (pulmonary vein isolation).
Who may be able to join
- Symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug
- Age 18-75 yrs
- First catheter ablation
Who cannot join
- Left ventricle ejection fraction at echocardiography <50%
- History of heart surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation
Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.
Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.
Read more
Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.
Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.
- Conditions
- Paroxysmal Atrial Fibrillation, Catheter Ablation
- Keywords
- atrial fibrillation, paroxysmal, contact force, radiofrequency, catheter ablation, pulmonary vein isolation, recurrence, follow-up
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc. | |
| CF group | Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of PVI after exclusive anatomic approach
Measured: Day 0
Proportion of patients free of AF after 12-month FU
Measured: One year
Secondary outcomes (3)
Total time of fluoroscopy and radiation exposure
Measured: Day 0
Total time of RF application required for completed PVI
Measured: Day 0
Proportion of pericardial effusion at echocardiography
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startNov 2010
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JP Albenque, Clinique Pasteur
- Investigators
- Jean-Paul Albenque, M.D., Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630031
- Sponsor's protocol ID
- 1
- Status last verified
- Jun 2012
- First submitted
- 23 Jun 2012
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Marijon E, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J Cardiovasc Electrophysiol. 2014 Feb;25(2):130-7. doi: 10.1111/jce.12303. Epub 2013 Nov 6.
PubMed 24433324
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Vein Isolation: Interest of Real-Time Contact Force Sensing During Radiofrequency Catheter Ablation for Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01630031
- Acronym / sponsor ID
- 1
- Conditions
- Paroxysmal Atrial Fibrillation, Catheter Ablation
- Keywords
- atrial fibrillation, paroxysmal, contact force, radiofrequency, catheter ablation, pulmonary vein isolation, recurrence, follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 28 Jun 2012 (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.
Introduction - Pulmonary vein isolation (PVI) is the cornerstone of paroxysmal atrial fibrillation (AF) ablation. Recurrences remain, however, not infrequent and are mainly due to PVs reconnection. In this setting, all procedural means able to improve the quality of tissue lesions are welcome.
Study Hypothesis - A continuous sensing of contact force (CF) during ablation, offered by a new catheter available on the market, was a valuable additional tool increasing the efficacy of the ablation procedure for PVI.
Methods - Prospective observational non-randomized monocentric study. Patients with paroxysmal AF receive PVI following standard ablation procedures (linear antral catheter ablation guided by CARTO 3 System, Biosense Webster, Inc.) using either a new irrigated RF ablation catheter that provides tip-to-tissue CF information (THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc.) (CF group), or a non-CF irrigated catheter (THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc.) (control group). Overall, 60 consecutive patients are enrolled in the study, with 30 patients in each group. All procedures is performed by the same experienced operator, not blinded to the catheter used. Except for CF information (with an objective of at least 10 g, associated to the most perpendicular vector obtainable), ablation procedures are carried out using identical approaches in both groups. Patients are discharged from hospital free of antiarrhythmic therapy. Patients are enrolled in a specific follow-up plan.
Primary Endpoints -(1) Proportion of PVI after exclusive anatomic approach, (2) Proportion of patients free of AF after 12-month follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Use of the THERMOCOOL SF or EZ STEER THERMOCOOL Catheter, Biosense Webster, Inc. |
| CF group | – | –Use of THERMOCOOL SMARTTOUCH Catheter, Biosense Webster, Inc. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population included patients with paroxysmal atrial fibrillation who undergo a first catheter ablation procedure (pulmonary vein isolation).
Key inclusion criteria (3 listed)
- Symptomatic paroxysmal atrial fibrillation despite at least failure of one anti-arrhythmic drug
- Age 18-75 yrs
- First catheter ablation
Key exclusion criteria (2 listed)
- Left ventricle ejection fraction at echocardiography <50%
- History of heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of PVI after exclusive anatomic approach
Time frame: Day 0
Proportion of patients free of AF after 12-month FU
Time frame: One year
3 secondary outcomes
Total time of fluoroscopy and radiation exposure
Time frame: Day 0
Total time of RF application required for completed PVI
Time frame: Day 0
Proportion of pericardial effusion at echocardiography
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2012.
- Derived from this study: PubMed 24433324Marijon E, Fazaa S, Narayanan K, Guy-Moyat B, Bouzeman A, Providencia R, Treguer F, Combes N, Bortone A, Boveda S, Combes S, Albenque JP. Real-time contact force sensing for pulmonary vein isolation in the setting of paroxysmal atrial fibrillation: procedural and 1-year results. J Cardiovasc Electrophysiol. 2014 Feb;25(2):130-7. doi: 10.1111/jce.12303. Epub 2013 Nov 6.
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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.
Jean-Paul Albenque, M.D. principal investigator
Clinique Pasteur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation and Catheter Ablation, run by Clinique Pasteur 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 3 inclusion and 2 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 28 Jun 2012. 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?
Proportion of PVI after exclusive anatomic approach (time frame: Day 0). 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?
On the ClinicalTrials.gov record for NCT01630031, which also lists 1 linked publication.
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 28 Jun 2012.