Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
Primary Purpose
Ventricular Arrhythmias and Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ablation plus ICD
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Arrhythmias and Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- IRCCS Policlinico S. DonatoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Ablation plus ICD
ICD alone
Arm Description
Epicardial ablation by radio-frequency
Implantation of ICD
Outcomes
Primary Outcome Measures
Survival from any VA recurrence will be considered as primary endpoint
NO ventricular arrhythmia recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT03294278
First Posted
September 22, 2017
Last Updated
September 28, 2023
Sponsor
IRCCS Policlinico S. Donato
1. Study Identification
Unique Protocol Identification Number
NCT03294278
Brief Title
Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
Official Title
Epicardial Ablation in Brugada Syndrome in the Prevention of Sudden Cardiac Death. A Randomized Prospective Follow-up Study.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Policlinico S. Donato
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmias and Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ablation plus ICD
Arm Type
Active Comparator
Arm Description
Epicardial ablation by radio-frequency
Arm Title
ICD alone
Arm Type
Active Comparator
Arm Description
Implantation of ICD
Intervention Type
Other
Intervention Name(s)
ablation plus ICD
Intervention Description
Defibrillator, radio-frequency catheter ablation
Primary Outcome Measure Information:
Title
Survival from any VA recurrence will be considered as primary endpoint
Description
NO ventricular arrhythmia recurrence
Time Frame
2 years after ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carlo Pappone, MD
Phone
+39 02 52774260
Email
carlo.pappone@af-ablation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD
Organizational Affiliation
IRCCS Policlinico San Donato Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Policlinico S. Donato
City
San Donato Milanese
State/Province
Milano
ZIP/Postal Code
20097
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Pappone, MD, PhD
Phone
00390252774260
Email
carlo.pappone@af-ablation.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Epicardial Ablation in Brugada Syndrome to Prevent Sudden Death
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