Ventricular Arrhythmias and Cardiac ArrestNCT03294278
Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
A study testing ablation plus ICD in people with Ventricular Arrhythmias and Cardiac Arrest, run by IRCCS Policlinico S. Donato at 1 site in Italy.
Trial summary
A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventricular Arrhythmias and Cardiac Arrest
- What is being tested?
- ablation plus ICD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 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
- Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS
- Consensus document criteria
- The patient received at least 1 appropriate ICD shock.
- Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000;
- Age ≥ 18;
- Willingness to attend follow-up examinations;
- Written informed consent for participation in the trial.
Who cannot join
- A patient who does not meet inclusion criteria;
- Pregnancy or breast-feeding (which would exclude an ablation procedure);
- Contraindications to general anesthesia or epicardial ablation;
- Life expectancy < 12 months
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 Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).
Read the detailed description
The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).
Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.
A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).
- Being tested
- ablation plus ICD
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablation plus ICDOther
Defibrillator, radio-frequency catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| Ablation plus ICD | Active comparator | Epicardial ablation by radio-frequency Receives: Other: ablation plus ICD |
| ICD alone | Active comparator | Implantation of ICD Receives: Other: ablation plus ICD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival from any VA recurrence will be considered as primary endpoint
NO ventricular arrhythmia recurrence
Measured: 2 years after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start10 Sep 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 (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular Arrhythmias and Cardiac ArrestStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 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, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03294278
- Sponsor's protocol ID
- IRCCSDonato Brugada-randomized
- Status last verified
- Sep 2023
- First submitted
- 22 Sep 2017
- Last updated
- 29 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pappone C, Ciconte G, Vicedomini G, Micaglio E, Boccellino A, Negro G, Giannelli L, Rondine R, Creo P, Tarantino A, Ballarotto M, Maiolo V, Ciaccio C, Manuello R, Locati ET, Mazza BC, Vecchi M, Calovic Z, Anastasia L. Epicardial ablation in high-risk Brugada syndrome to prevent ventricular fibrillation: results from a randomized clinical trial. Europace. 2025 May 7;27(5):euaf097. doi: 10.1093/europace/euaf097.
PubMed 40401314
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
- ClinicalTrials.gov ID
- NCT03294278
- Acronym / sponsor ID
- IRCCSDonato Brugada-randomized
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IRCCS Policlinico S. DonatoUniversity, hospital or other
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 28 Sep 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 27 Sep 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.
A total of 150 patients will be randomized to perform catheter ablation or not in a 2:1 fashion in selected patients with Brugada-related symptoms (Ablation+ICD arm 105 patients vs ICD only 45 patients).
Detailed description
The main purpose of this trial is to develop evidence-based curative treatment with optimal net benefit for patients with Brugada syndrome. As recent non-randomized pilot studies and scarce case reports documented the potential benefit of epicardial ablation, patients in this trial will be randomized to epicardial catheter ablation of the regions exhibiting abnormally prolonged and fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (ablation arm) or continued implanted cardioverter defibrillator therapy (control arm).
Survival from any ventricular arrhythmia (VA) recurrence will be considered as primary endpoint.
A projected 150 patients will be enrolled and randomized to receive ablation or not in a 2:1 fashion (Ablation+ICD arm 105 patients vs ICD only 45 patients).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation plus ICD | Active comparator | Other: ablation plus ICDEpicardial ablation by radio-frequency |
| ICD alone | Active comparator | Other: ablation plus ICDImplantation of ICD |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients affected by Brugada Syndrome diagnosed according to 2013 HRS/EHRA/APHRS
- Consensus document criteria
- The patient received at least 1 appropriate ICD shock.
- Documentation of any previous ventricular arrhythmia (VA) in the form of VT, non-sustained VT, non-sustained VF, RVOT PVC with a daily burden >10000;
- Age ≥ 18;
Key exclusion criteria (4 listed)
- A patient who does not meet inclusion criteria;
- Pregnancy or breast-feeding (which would exclude an ablation procedure);
- Contraindications to general anesthesia or epicardial ablation;
- Life expectancy < 12 months
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 |
|---|---|---|
| ablation plus ICDDefibrillator, radio-frequency catheter ablation | Other | Ablation plus ICD, ICD alone |
Primary outcome
Survival from any VA recurrence will be considered as primary endpoint
Time frame: 2 years after ablation
NO ventricular arrhythmia recurrence
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2023.
- Derived from this study: PubMed 40401314Pappone C, Ciconte G, Vicedomini G, Micaglio E, Boccellino A, Negro G, Giannelli L, Rondine R, Creo P, Tarantino A, Ballarotto M, Maiolo V, Ciaccio C, Manuello R, Locati ET, Mazza BC, Vecchi M, Calovic Z, Anastasia L. Epicardial ablation in high-risk Brugada syndrome to prevent ventricular fibrillation: results from a randomized clinical trial. Europace. 2025 May 7;27(5):euaf097. doi: 10.1093/europace/euaf097.
- 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.
Carlo Pappone, MD principal investigator
IRCCS Policlinico San Donato Milan, Italy
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 plus ICD in people with Ventricular Arrhythmias and Cardiac Arrest, 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 7 inclusion and 4 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 29 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 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?
Survival from any VA recurrence will be considered as primary endpoint (time frame: 2 years after ablation). 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 NCT03294278, 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 29 Sep 2023.