ECG Brugada PatternNCT03106701
Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients
A study testing Ablation in people with ECG Brugada Pattern, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ECG Brugada Pattern
- What is being tested?
- Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 14 Mar 2017to 30 Dec 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.
Who cannot join
- Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Policlinico S. Donato
San Donato Milanese, Milano, 20097
Carlo Pappone, MD, PhD, 00390252774260, carlo.pappone@af-ablation.org
About this study
Official title: Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
This study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.
Read the detailed description
According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.
- Conditions
- ECG Brugada Pattern
- Being tested
- Ablation
- Medical subject headings
- Brugada Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Epicardial Radiofrequency ablation
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Experimental | Radiofrequency epicardial ablation Receives: Procedure: Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.
Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials
Measured: 1 day after ablation
VT/VF inducibility
Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.
Measured: immediately after mapping and ablation
Absence of VT/VF
Absence of VT/VF by ICD interrogation
Measured: 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Secondary outcomes (13)
Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test
Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline.
Measured: 3 months
Absence of VA episodes at EP study
Non-inducibility of VT/VT at programmed electrophysiological study
Measured: 3 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test
Measured: 6 months
Absence of VA episodes
ICD interrogation
Measured: 6 months
Absence of VA episodes
ICD interrogation and ajmaline test
Measured: 12 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test
Measured: 12 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Measured: 18 months
Absence of VA episodes
ICD interrogation
Measured: 24 months
Absence of Br ECG pattern after ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Measured: 24 months
Absence of VA episodes at EP study
ICD interrogation
Measured: 36 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Measured: 36 months
Absence of Br Pattern at ajmaline test
Normalization of 12-lead ECG recording at baseline and after ajmaline test
Measured: 48 months
Absence of VA episodes at EP study
ICD interrogation
Measured: 48 months up to 120 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start14 Mar 2017
- Primary completion28 Sep 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ECG Brugada PatternStudies of the same condition, open and under way.
- More trials run by IRCCS Policlinico S. DonatoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Policlinico S. Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Pappone, IRCCS Policlinico S. Donato
- Investigators
- Carlo Pappone, MD, Principal investigator, IRCCS Policlinico San Donato, Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106701
- Sponsor's protocol ID
- IRCCSDonato
- Status last verified
- Sep 2023
- First submitted
- 14 Mar 2017
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciconte G, Santinelli V, Vicedomini G, Borrelli V, Monasky MM, Micaglio E, Giannelli L, Negro G, Giordano F, Mecarocci V, Mazza BC, Locati E, Anastasia L, Calovic Z, Pappone C. Non-invasive assessment of the arrhythmogenic substrate in Brugada syndrome using signal-averaged electrocardiogram: clinical implications from a prospective clinical trial. Europace. 2019 Dec 1;21(12):1900-1910. doi: 10.1093/europace/euz295.
PubMed 31647530Ciconte G, Santinelli V, Brugada J, Vicedomini G, Conti M, Monasky MM, Borrelli V, Castracane W, Aloisio T, Giannelli L, Di Dedda U, Pozzi P, Ranucci M, Pappone C. General Anesthesia Attenuates Brugada Syndrome Phenotype Expression: Clinical Implications From a Prospective Clinical Trial. JACC Clin Electrophysiol. 2018 Apr;4(4):518-530. doi: 10.1016/j.jacep.2017.11.013. Epub 2018 Feb 13.
PubMed 30067493Pappone C, Ciconte G, Manguso F, Vicedomini G, Mecarocci V, Conti M, Giannelli L, Pozzi P, Borrelli V, Menicanti L, Calovic Z, Della Ratta G, Brugada J, Santinelli V. Assessing the Malignant Ventricular Arrhythmic Substrate in Patients With Brugada Syndrome. J Am Coll Cardiol. 2018 Apr 17;71(15):1631-1646. doi: 10.1016/j.jacc.2018.02.022.
PubMed 29650119
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
- ClinicalTrials.gov ID
- NCT03106701
- Acronym / sponsor ID
- IRCCSDonato
- Conditions
- ECG Brugada Pattern
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 10 Apr 2017 (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 study represents an extension of a previous study (NCT02641431) on the acute and long-term benefit of epicardial ablation on elimination of both BrS-ECG pattern and VT/VF inducibility in 500 consecutive BrS patients.
Detailed description
According to previous protocol (NCT02641431), 300 additional consecutive selected patients having an ICD implantation will be enrolled up to a total of 500 BrS patients. Echocardiography with cardiac deformation analysis, three-dimensional color-coded voltage, activation and duration electroanatomical maps before and after ajmaline (1mg/kg in 5 minutes) wiil determine the site and the size of the arrhythmogenic substrate as characterized by abnormally prolonged fragmented ventricular potentials and potential wall motion abnormalities. Primary endpoint will be identification and elimination of this electrophysiological substrate by RF applications leading to ECG pattern normalization and VT/VF non-inducibility before and after ajmaline. Patients will be followed up to 10 years after ablation by sequential 12-lead ECG and Holter recording, Echocardiography, ICD interrogation, VT/VF inducibility patterns before and after ajmaline test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ablation | Experimental | Procedure: AblationRadiofrequency epicardial ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic BrS patients with typical BrS-related symptoms (cardiac arrest or syncope) or without typical BrS-related symptoms (dizziness, palpitations, presyncope, dyspnea) ICD implantation, spontaneous or ajmaline-induced type 1 Br pattern.
Key exclusion criteria (1 listed)
- Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities.
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 |
|---|---|---|
| AblationEpicardial Radiofrequency ablation | Procedure or surgery | Ablation |
Primary outcome
Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test.
Time frame: 1 day after ablation
Normalization of ECG pattern after elimination by radio-frequency ablation of all abnormal epicardial potentials
VT/VF inducibility
Time frame: immediately after mapping and ablation
Programmed stimulation was achieved at twice the diastolic threshold and randomly performed at RV apex and RV outflow tract using up to 3 drive cycle lengths (from 600 to 350ms) and up to three extrastimuli (S2-S4) delivered from the apex and outflow tract of the right ventricle.
Absence of VT/VF
Time frame: 1,3,6,12,18,24,36,48,60,72,84,96,108,120 months after ablation
Absence of VT/VF by ICD interrogation
13 secondary outcomes
Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test
Time frame: 3 months
Absence of VA episodes at EP study
Time frame: 3 months
Absence of Br Pattern at ajmaline test
Time frame: 6 months
Absence of VA episodes
Time frame: 6 months
Absence of VA episodes
Time frame: 12 months
Absence of Br Pattern at ajmaline test
Time frame: 12 months
Absence of Br Pattern at ajmaline test
Time frame: 18 months
Absence of VA episodes
Time frame: 24 months
Absence of Br ECG pattern after ajmaline test
Time frame: 24 months
Absence of VA episodes at EP study
Time frame: 36 months
Absence of Br Pattern at ajmaline test
Time frame: 36 months
Absence of Br Pattern at ajmaline test
Time frame: 48 months
Absence of VA episodes at EP study
Time frame: 48 months up to 120 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Derived from this study: PubMed 31647530Ciconte G, Santinelli V, Vicedomini G, Borrelli V, Monasky MM, Micaglio E, Giannelli L, Negro G, Giordano F, Mecarocci V, Mazza BC, Locati E, Anastasia L, Calovic Z, Pappone C. Non-invasive assessment of the arrhythmogenic substrate in Brugada syndrome using signal-averaged electrocardiogram: clinical implications from a prospective clinical trial. Europace. 2019 Dec 1;21(12):1900-1910. doi: 10.1093/europace/euz295.
- Derived from this study: PubMed 30067493Ciconte G, Santinelli V, Brugada J, Vicedomini G, Conti M, Monasky MM, Borrelli V, Castracane W, Aloisio T, Giannelli L, Di Dedda U, Pozzi P, Ranucci M, Pappone C. General Anesthesia Attenuates Brugada Syndrome Phenotype Expression: Clinical Implications From a Prospective Clinical Trial. JACC Clin Electrophysiol. 2018 Apr;4(4):518-530. doi: 10.1016/j.jacep.2017.11.013. Epub 2018 Feb 13.
- Derived from this study: PubMed 29650119Pappone C, Ciconte G, Manguso F, Vicedomini G, Mecarocci V, Conti M, Giannelli L, Pozzi P, Borrelli V, Menicanti L, Calovic Z, Della Ratta G, Brugada J, Santinelli V. Assessing the Malignant Ventricular Arrhythmic Substrate in Patients With Brugada Syndrome. J Am Coll Cardiol. 2018 Apr 17;71(15):1631-1646. doi: 10.1016/j.jacc.2018.02.022.
- Individual participant dataSharing planned: No
Related trials for ECG Brugada Pattern
Recruiting
Brugada Syndrome Substrate Characterization and Ablation
Brugada Syndrome
RecruitingObservational study
Unmasking Concealed Arrhythmia Syndromes
Brugada ECG Patterns, Brugada Syndrome (BrS)
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.
Carlo Pappone, MD principal investigator
IRCCS Policlinico San Donato, Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation in people with ECG Brugada Pattern, run by IRCCS Policlinico S. Donato at 1 site in Italy.
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 1 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: status not confirmed, as of the sponsor's last update on 2 Oct 2023. 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 Italy. 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 Carlo Pappone, MD (+39 02 52774260, carlo.pappone@af-ablation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 1 BrS-ECG pattern elimination by epicardial ablation before and after ajmaline test. (time frame: 1 day after ablation). The study lists 3 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 NCT03106701, which also lists 3 linked publications.
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 Oct 2023.