Ablation in Brugada Syndrome for the Prevention of VF (BRAVE)

• ClinicalTrials.gov Identifier: NCT02704416
• Recruitment Status: Recruiting
• First Posted: March 10, 2016
• Last Update Posted: April 12, 2022
• Sponsor: Pacific Rim Electrophysiology Research Institute
• Collaborator: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Information provided by (Responsible Party): Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Brugada Syndrome	Procedure: Catheter Ablation	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: July 2016
• Estimated Primary Completion Date: July 2023
• Estimated Study Completion Date: July 2023

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control arm; Control arm - continued implanted cardioverter defibrillator therapy
Active Comparator: Intervention Arm; ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy	Procedure: Catheter Ablation; catheter ablation of fragmented signal in the right ventricular outflow tract
Single Cross Over Arm; these patients were initially assigned to the control arm of the study. When these patients met the primary outcome of the study it is allowed for these patients to be included in the intervention arm and/or to start quinidine	Procedure: Catheter Ablation; catheter ablation of fragmented signal in the right ventricular outflow tract

Outcome Measures

Primary Outcome Measures :

1. Freedom of Ventricular Fibrillation/Tachycardia Recurrences [ Time Frame: 3 year followup ]
   Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge

Secondary Outcome Measures :

1. Freedom without drug [ Time Frame: 3 years ]
   Freedom of shocked ventricular arrhythmias without the use of anti-arrhythmic drugs during 3 years of follow-up

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Koonlawee Nademanee, MD; 66870708787; koonlawee@pacificrimep.com

Locations

Netherlands

Academic Medical Center, University of Amsterdam; Not yet recruiting

Amsterdam, Netherlands

Contact: Pieter G Postema, MD PhD p.g.postema@amc.nl

Principal Investigator: Pieter G Postema, MD PhD

Sub-Investigator: Arthur A Wilde, MD PhD

Thailand

Bhumipol Adulyadej Hospital, Royal Thai Air Force; Recruiting

Bangkok, Thailand

Contact: Gumpanart Veerakul, MD

Principal Investigator: Gumpanart Veerakul, MD

Principal Investigator: Koonlawee Nademanee, MD

Chulalongkorn University; Recruiting

Bangkok, Thailand

Contact: Apichai Khong, MD

Principal Investigator: Apichai Khong, MD

Pacific Rim Electrophysiology Research Institute Data Coordinating Center; Recruiting

Bangkok, Thailand

Contact: Koonlawee Nademanee, MD 66870708787 koonlawee@pacificrimep.com

Principal Investigator: Koonlawee Nademanee, MD

Ramathibodi Hospital; Recruiting

Bangkok, Thailand

Contact: Tachapong Ngarmukos, MD

Chiang Mai University; Recruiting

Chiang Mai, Thailand

Contact: Wanwarang Wongcharoen, MD 053-289177

Sponsors and Collaborators

Pacific Rim Electrophysiology Research Institute

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

• Principal Investigator: Koonlawee Nademanee, MD; Pacific Rim Electrophysiology Research Institute

More Information

Publications:

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.

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.

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.

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.

• Responsible Party: Koonlawee Nademanee, MD, Principal Investigator, Pacific Rim Electrophysiology Research Institute
• ClinicalTrials.gov Identifier: NCT02704416
• Other Study ID Numbers: PacificRERI
• First Posted: March 10, 2016
• Last Update Posted: April 12, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Medical journals, abstract submissions and results database

Keywords provided by Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute:

Ventricular arrhythmias; aborted cardiac arrest; cardiac death

Additional relevant MeSH terms:

Brugada Syndrome; Syndrome; Disease; Pathologic Processes; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn