Cardiovascular DiseasesSCAR-AFNCT04045067
Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation
An observational study of Cardiovascular Diseases and Atrial Fibrillation, Persistent, run by French Cardiology Society at 9 sites in France.
Trial summary
This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Atrial Fibrillation, Persistent
- What is being tested?
- Isolation of pulmonary veins and Ablation by radiofrequency of low-voltage areas
- Type of treatment
- Surgery or procedure
- How many people
- 212 participants
- Where
- 9 sitesFrance
- Study dates
- 25 Sep 2019to 11 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients included in this protocol will be recruited by the centers that practice the procedure of ablation of persistent atrial fibrillation, by transcutaneous vein and trans-septal catheterization. Participation in this prospective observational study has been proposed to all centers practicing this procedure in France, regardless of the technique used. Inclusion in the study will be systematically offered to each patient who will benefit from this technique.
Who may be able to join
- Patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure
- Patients participating in a biomedical research can participate in this study.
Who cannot join
- Pregnant or lactating women can not participate in this study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Centre Hospitalier Universitaire d'Angers
Angers, 49100
Clinique de l'Infirmerie Protestante de Lyon
Caluire-et-Cuire, 69300
Centre Hospitalier Saint Joseph Saint Luc
Lyon, 69007
Hôpital Saint-Joseph
Marseille, 13008
Hôpital Privé Beauregard
Marseille, 13012
Clinique Ambroise Paré
Neuilly-sur-Seine, 92200
Hôpital Universitaire Pitié Salpêtrière
Paris, 75013
Centre Cardiologique du Nord
Saint-Denis, 93200
Clinique Saint Gatien
Tours, 37000
About this study
This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.
Read the detailed description
Radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. The interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. The usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. The isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. This strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. On the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. In addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. Once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. Ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.
- Being tested
- Isolation of pulmonary veins, Ablation by radiofrequency of low-voltage areas
- Keywords
- Ablation, Low voltage areas
- Medical subject headings
- Cardiovascular Diseases, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of pulmonary veinsProcedure or surgery
Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.
Ablation by radiofrequency of low-voltage areasProcedure or surgery
The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | A group of patients who have pulmonary vein isolation alone, without low-voltage areas identified. Receives: Procedure: Isolation of pulmonary veins | |
| Group 2 | A group of patients who have pulmonary veins isolation alone, with low-voltage areas identified but the complementary defragmentation will not be carried out. Receives: Procedure: Isolation of pulmonary veins | |
| Group 3 | A group of patients who have pulmonary veins isolation, with low-voltage areas identified and the complementary defragmentation will be carried out. Receives: Procedure: Isolation of pulmonary veins; Procedure: Ablation by radiofrequency of low-voltage areas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the success rate of the procedures
Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation
Measured: month 18
Secondary outcomes (2)
Evaluation of the efficiency of the procedures
Comparison between the 3 study arms of the duration of the intervention (in minutes), the duration of fluoroscopy (in minutes), rate of X-ray doses delivered during the procedure (in mGym² (milligray per meter²), the induction of atrial fibrillation at the end of the procedure or not.
Measured: Day 1
Evaluation of the safety of the procedures
Comparison between the 3 study arms of the number and type of events regarding the types of procedure: pericardial effusion, pericardial drainage, vascular complication, ischemic stroke, heart failure, acute coronary syndrome, new atrial fibrillation episode, death.
Measured: Day 1 / month 3 / month 6 / month 12 / month 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start25 Sep 2019
- Primary completion11 Sep 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine LEPILLIER, MD, Principal investigator, Centre Cardiologique du Nord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045067
- Sponsor's protocol ID
- 2019-02
- Acronym
- SCAR-AF
- Status last verified
- Sep 2023
- First submitted
- 1 Aug 2019
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-voltage Areas Defragmentation in Sinus Rhythm for Radiofrequency Ablation of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04045067
- Acronym / sponsor ID
- SCAR-AF / 2019-02
- Keywords
- Ablation, Low voltage areas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 5 Aug 2019 (actual)
- 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.
This is a study evaluating the value of defragmentation of sinus rhythmic low voltage areas in addition to isolation of pulmonary veins in the removal of recurrent atrial fibrillation. The invasive procedure will be performed according to the procedures chosen by the rhythmologist and will in no way be modified by the patient's enrollment in the study. Similarly, the frequency of consultations, date and nature of the additional examinations will be defined by the physician, with the purpose of monitoring the patient.
Detailed description
Radiofrequency ablation has become standard practice in the approach strategy for the symptomatic treatment of atrial fibrillation. The interest of substrate ablation, completing the isolation of the pulmonary veins is controversial. The usual technique for the ablation of recurrent atrial fibrillation is primarily a disconnection of the pulmonary veins, which can be accomplished by isolating the veins one by one or two by two. The isolation of the pulmonary veins is followed most often by a defragmentation of the atrium (ablation of the substrate). The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. This strategy requires extensive ablation of the left atrium, with a long procedure time and repeated many radiofrequency shots. On the one hand there is a risk of complication related to the duration of intervention, but also in the longer term of occurrence of flutter scar. In addition to pulmonary vein isolation, the goal is to identify patients with sinus rhythm atrial arrhythmogenic substrate. Once the sinus rhythm has been restored by electrical cardioversion or spontaneously, a voltage map is carried out to identify the most abnormal (low voltage) areas, and intra-atrial fragmented potentials are identified, either spontaneously or spontaneously by the extra-stimulus method. Ablation of these abnormal areas may lead to better long-term results, limiting prolonged radiofrequency shots and complications associated with longer procedure times.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: Isolation of pulmonary veinsA group of patients who have pulmonary vein isolation alone, without low-voltage areas identified. |
| Group 2 | – | Procedure: Isolation of pulmonary veinsA group of patients who have pulmonary veins isolation alone, with low-voltage areas identified but the complementary defragmentation will not be carried out. |
| Group 3 | – | Procedure: Isolation of pulmonary veins, Procedure: Ablation by radiofrequency of low-voltage areasA group of patients who have pulmonary veins isolation, with low-voltage areas identified and the complementary defragmentation will be carried out. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in this protocol will be recruited by the centers that practice the procedure of ablation of persistent atrial fibrillation, by transcutaneous vein and trans-septal catheterization. Participation in this prospective observational study has been proposed to all centers practicing this procedure in France, regardless of the technique used. Inclusion in the study will be systematically offered to each patient who will benefit from this technique.
Key inclusion criteria (2 listed)
- Patients with persistent atrial fibrillation ablation, no specific indication restrictions or equipment used and regardless of the outcome of the procedure
- Patients participating in a biomedical research can participate in this study.
Key exclusion criteria (1 listed)
- Pregnant or lactating women can not participate in this study
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 |
|---|---|---|
| Isolation of pulmonary veinsLow voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins. | Procedure or surgery | Group 1, Group 2, Group 3 |
| Ablation by radiofrequency of low-voltage areasThe defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation. | Procedure or surgery | Group 3 |
Primary outcome
Evaluation of the success rate of the procedures
Time frame: month 18
Comparison between the 3 study arms of the number of new episodes of symptomatic atrial fibrillation
2 secondary outcomes
Evaluation of the efficiency of the procedures
Time frame: Day 1
Evaluation of the safety of the procedures
Time frame: Day 1 / month 3 / month 6 / month 12 / month 18
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 13 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Antoine LEPILLIER, MD principal investigator
Centre Cardiologique du Nord
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Atrial Fibrillation, Persistent, run by French Cardiology Society at 9 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 2 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 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?
Evaluation of the success rate of the procedures (time frame: month 18). 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 13 Sep 2023.