Brugada Syndrome Type 1SB-CARTONCT03572881
Rhythmic Risk of Type 1 Brugada Syndrome and Pulmonary Infundibulum Mapping
A study testing Endocardial mapping in people with Brugada Syndrome Type 1, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. Read more about this study
- Who is it for?
- Ages 18 months and older
- Conditions the study is for
- Brugada Syndrome Type 1
- What is being tested?
- Endocardial mapping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2018to Jan 2019
- 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 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Group 21
- Brugada Type 1 syndrome
- Age : 50-60 years old
- Asymptomatic
- Signed informed consent
- Group2
Show all 12Show fewer
- Brugada Type 1 syndrome
- Age >18 years old
- Implantable defibrillator
- Having received at least 1 appropriate shock or a sudden sudden death
- Signed informed consent
- Groups 1 and 2
Who cannot join
- Brugada Type 2 or 3 syndrome
- Contraindication to electrophysiological exploration
Trial locations and contacts
1 site in 1 country.
France1 site
Hopital Louis Pradel
Bron
Philippe Chevalier, Pr, 4 72 35 70 27 ext. +33, philippe.chevalier@chu-lyon.fr
Elodie Morel, CRA, 4 72 35 73 81 ext. +33, elodie.morel01@chu-lyon.fr
About this study
Official title: Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping
Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.
Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.
The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.
- Conditions
- Brugada Syndrome Type 1
- Being tested
- Endocardial mapping
- Keywords
- Brugada syndrome, ventricular arrhythmia, sudden death
- Medical subject headings
- Brugada Syndrome, Death, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endocardial mappingDevice
An endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1.
| Study group | Role | What they receive |
|---|---|---|
| Asymptomatic | Experimental | Not described Receives: Device: Endocardial mapping |
| Symptomatic | Experimental | Not described Receives: Device: Endocardial mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1
The voltage zone are defined with :
- measurement of unipolar and bipolar local voltage (mV)
- the scar surface
- the surface of the bordering area
- the surface of healthy tissue
- the quantification of the number of fractionated potentials and density with respect to the size of the infundibulum and the scar (if present)
- the analysis of the heterogeneity of the voltage (study of dispersion)
- analysis of propagation card velocities in sinus rhythm and ventricular pacing (mm / s)
- analysis of ventricular arrhythmia activation if positive ventricular pacing and good hemodynamic tolerance (focal / reentrant / reentrant macro).
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 2018
- Study startJul 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brugada Syndrome Type 1Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572881
- Sponsor's protocol ID
- 69HCL18_0279
- Acronym
- SB-CARTO
- Status last verified
- Jun 2018
- First submitted
- 19 Jun 2018
- Last updated
- 28 Jun 2018
- 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 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Rhythmic Risk in Patients With Type 1 Brugada Syndrome by Pulmonary Infundibulum Mapping
- ClinicalTrials.gov ID
- NCT03572881
- Acronym / sponsor ID
- SB-CARTO / 69HCL18_0279
- Conditions
- Brugada Syndrome Type 1
- Keywords
- Brugada syndrome, ventricular arrhythmia, sudden death
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 28 Jun 2018 (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.
Brugada syndrome has been described as the association of a right bundle block with ST segment elevation on the V1 to V3 electrocardiogram in patients with a structurally normal heart. The rhythmic risk is thus difficult to evaluate in asymptomatic patients in whom the rate of events is estimated at 0.2 to 1.4% of events per year. In addition, the predictive value of ventricular pacing remains controversial; There is therefore currently no review to effectively assess rhythmic risk in patients with Brugada type I syndrome.
Investigators aimed to show a difference in pulmonary infundibulum voltage mapping in symptomatic and asymptomatic patients with Brugada type 1 syndrome with a comparable ECG.
The mapping of the pulmonary infundibulum will be performed during electrophysiological exploration. Only the catheter used differs from the usual procedure.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asymptomatic | Experimental | Device: Endocardial mapping |
| Symptomatic | Experimental | Device: Endocardial mapping |
Who may qualify
- Ages
- 18 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Group 21
- Brugada Type 1 syndrome
- Age : 50-60 years old
- Asymptomatic
- Signed informed consent
Key exclusion criteria (2 listed)
- Brugada Type 2 or 3 syndrome
- Contraindication to electrophysiological exploration
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 |
|---|---|---|
| Endocardial mappingAn endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1. | Device | Asymptomatic, Symptomatic |
Primary outcome
Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1
Time frame: Day 1
The voltage zone are defined with : * measurement of unipolar and bipolar local voltage (mV) * the scar surface * the surface of the bordering area * the surface of healthy tissue * the quantification of the number of fractionated potentials and density with respect to the size of the infundibulum and the scar (if present) * the analysis of the heterogeneity of the voltage (study of dispersion) * analysis of propagation card velocities in sinus rhythm and ventricular pacing (mm / s) * analysis of ventricular arrhythmia activation if positive ventricular pacing and good hemodynamic tolerance (focal / reentrant / reentrant macro).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- Individual participant dataSharing planned: No
Related trials for Brugada Syndrome Type 1
Recruiting
Brugada Syndrome Substrate Characterization and Ablation
Brugada Syndrome
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endocardial mapping in people with Brugada Syndrome Type 1, run by Hospices Civils de Lyon 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 12 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 2018. 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?
Contact Philippe CHEVALIER, MD PhD, Pr (4 72 35 70 27 ext. +33, philippe.morel@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of different voltage zones by endocardial mapping of the pulmonary infundibulum between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1 (time frame: Day 1). 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 28 Jun 2018.