We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epicardial Ablation in Brugada Syndrome. An Extension Study of 500 BrS.Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03106701
Recruitment Status : Recruiting
First Posted : April 10, 2017
Last Update Posted : November 30, 2021
Sponsor:
Information provided by (Responsible Party):
Carlo Pappone, IRCCS Policlinico S. Donato

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
ECG Brugada Pattern Procedure: Ablation Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epicardial Ablation in 500 Consecutive Brugada Syndrome Patients
Actual Study Start Date : March 14, 2017
Estimated Primary Completion Date : June 15, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Ablation
Radiofrequency epicardial ablation
 Procedure: Ablation
Epicardial Radiofrequency ablation


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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


Secondary Outcome Measures :
  1. Absence of Br Pattern and RV mechanical abnormalities using echo and cardiac deformation analysis before and after ajmaline test [ Time Frame: 3 months ]
    Abolition of typical BrS-ECG pattern and RV mechanical abnormalities before and after ajmaline.

  2. Absence of VA episodes at EP study [ Time Frame: 3 months ]
    Non-inducibility of VT/VT at programmed electrophysiological study

  3. Absence of Br Pattern at ajmaline test [ Time Frame: 6 months ]
    Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test

  4. Absence of VA episodes [ Time Frame: 6 months ]
    ICD interrogation

  5. Absence of VA episodes [ Time Frame: 12 months ]
    ICD interrogation and ajmaline test

  6. Absence of Br Pattern at ajmaline test [ Time Frame: 12 months ]
    Normalization of 12-lead ECG recording and echo parameters at baseline and after ajmaline test

  7. Absence of Br Pattern at ajmaline test [ Time Frame: 18 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test

  8. Absence of VA episodes [ Time Frame: 24 months ]
    ICD interrogation

  9. Absence of Br ECG pattern after ajmaline test [ Time Frame: 24 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test

  10. Absence of VA episodes at EP study [ Time Frame: 36 months ]
    ICD interrogation

  11. Absence of Br Pattern at ajmaline test [ Time Frame: 36 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test

  12. Absence of Br Pattern at ajmaline test [ Time Frame: 48 months ]
    Normalization of 12-lead ECG recording at baseline and after ajmaline test

  13. Absence of VA episodes at EP study [ Time Frame: 48 months up to 120 months ]
    ICD interrogation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age < 18 years, prior epicardial ablation, pregnancy, co-morbidities.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03106701


Contacts
Layout table for location contacts
Contact: Carlo Pappone, MD +39 02 52774260 carlo.pappone@af-ablation.org

Locations
Layout table for location information
Italy
IRCCS Policlinico S. Donato Recruiting
San Donato Milanese, Milano, Italy, 20097
Contact: Carlo Pappone, MD, PhD    00390252774260    carlo.pappone@af-ablation.org   
Sponsors and Collaborators
IRCCS Policlinico S. Donato
Investigators
Layout table for investigator information
Principal Investigator: Carlo Pappone, MD IRCCS Policlinico San Donato, Milan
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Carlo Pappone, Department Director, MD, IRCCS Policlinico S. Donato
ClinicalTrials.gov Identifier: NCT03106701    
Other Study ID Numbers: IRCCSDonato
First Posted: April 10, 2017    Key Record Dates
Last Update Posted: November 30, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Brugada Syndrome
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Genetic Diseases, Inborn