Ablation in Brugada Syndrome for the Prevention of VF

Brugada Syndrome Clinical Trial

— BRAVE  

Official title:

Ablation in Brugada Syndrome for Prevention of VF - A Randomized, Multi-center Study of Epicardial Ablation in Brugada Syndrome Patients to Prevent Arrhythmia Recurrence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02704416
• Other study ID #: PacificRERI
• Status: Recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: July 2024

Study information

• Verified date: November 2023
• Source: Pacific Rim Electrophysiology Research Institute
• Contact: Koonlawee Nademanee, MD
• Phone: 66870708787
• Email: koonlawee[@]pacificrimep.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome.

Description:

This trial aims to develop evidence based curative treatment with optimal net benefit for patients with Brugada syndrome. Since a recent non-randomized pilot study and scarce case reports documented potential clinical benefit of epicardial ablation of fragmented electrograms in the region of the right ventricular outflow tract, patients in this trial will be randomized to continued implanted cardioverter defibrillator therapy (control arm) or ablation of areas of fragmented electrograms in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy (intervention arm). A projected 92 patients in each group will be studied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The diagnosis of Brugada syndrome is based on 2013 HRS/EHRA/APHRS Consensus document criteria
• Diagnosed symptomatic BrS with an implanted ICD within the last 5 years
• Diagnosed symptomatic BrS with an implanted ICD longer than 5 years but has at least 1 appropriate shock within the last 5 years
• The patient is legally competent, willing and able to undergo the study and signed the informed consent
• The patient is willing and able to adhere to the follow-up visit protocol

Exclusion Criteria:

• A patient who does not meet inclusion criteria
• A patient who has had a previous epicardial ablation
• A patient who is pregnant (which would exclude an ablation procedure)
• A patient with a co-morbid condition that possesses undue risk of general anesthesia or epicardial ablation
• A patient who has a history of radiation therapy on the thorax

Related Conditions & MeSH terms

• Brugada Syndrome
• Syndrome

Intervention

Procedure:
• Catheter Ablation
catheter ablation of fragmented signal in the right ventricular outflow tract

Locations

Country	Name	City	State
Netherlands	Academic Medical Center, University of Amsterdam	Amsterdam
Thailand	Bhumipol Adulyadej Hospital, Royal Thai Air Force	Bangkok
Thailand	Chulalongkorn University	Bangkok
Thailand	Pacific Rim Electrophysiology Research Institute Data Coordinating Center	Bangkok
Thailand	Ramathibodi Hospital	Bangkok
Thailand	Chiang Mai University	Chiang Mai

Sponsors (2)

Lead Sponsor	Collaborator
Pacific Rim Electrophysiology Research Institute	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Countries where clinical trial is conducted

Netherlands,  Thailand, 

References & Publications (4)

Nademanee K, Raju H, de Noronha SV, Papadakis M, Robinson L, Rothery S, Makita N, Kowase S, Boonmee N, Vitayakritsirikul V, Ratanarapee S, Sharma S, van der Wal AC, Christiansen M, Tan HL, Wilde AA, Nogami A, Sheppard MN, Veerakul G, Behr ER. Fibrosis, Connexin-43, and Conduction Abnormalities in the Brugada Syndrome. J Am Coll Cardiol. 2015 Nov 3;66(18):1976-1986. doi: 10.1016/j.jacc.2015.08.862. — View Citation

Nademanee K, Veerakul G, Chandanamattha P, Chaothawee L, Ariyachaipanich A, Jirasirirojanakorn K, Likittanasombat K, Bhuripanyo K, Ngarmukos T. Prevention of ventricular fibrillation episodes in Brugada syndrome by catheter ablation over the anterior right ventricular outflow tract epicardium. Circulation. 2011 Mar 29;123(12):1270-9. doi: 10.1161/CIRCULATIONAHA.110.972612. Epub 2011 Mar 14. — View Citation

Ten Sande JN, Coronel R, Conrath CE, Driessen AH, de Groot JR, Tan HL, Nademanee K, Wilde AA, de Bakker JM, van Dessel PF. ST-Segment Elevation and Fractionated Electrograms in Brugada Syndrome Patients Arise From the Same Structurally Abnormal Subepicardial RVOT Area but Have a Different Mechanism. Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1382-92. doi: 10.1161/CIRCEP.115.003366. Epub 2015 Oct 19. — View Citation

Wilde AA, Nademanee K. Epicardial Substrate Ablation in Brugada Syndrome: Time for a Randomized Trial! Circ Arrhythm Electrophysiol. 2015 Dec;8(6):1306-8. doi: 10.1161/CIRCEP.115.003500. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom of Ventricular Fibrillation/Tachycardia Recurrences	Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge	3 year followup
Secondary	Freedom without drug	Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up	3 years