Ablation in Brugada Syndrome for the Prevention of VF

NCT02704416 | Completed DMC

• 1 other identifier: PacificRERI
• Study Type: interventional
• Target: 200
• Locations: 2 countries
• Sites: 6

Brief Summary

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

Conditions

Brugada Syndrome

Keywords

Ventricular arrhythmias; aborted cardiac arrest; cardiac death

Outcome Measures

Primary Outcomes (1)

• Freedom of Ventricular Fibrillation/Tachycardia Recurrences

  Survival from ventricular fibrillation of shocked ventricular arrhythmias causing ICD discharge

  3 year followup

Secondary Outcomes (1)

• Freedom without drug

  3 years

Study Arms (3)

Control arm

NO INTERVENTION

Control arm - continued implanted cardioverter defibrillator therapy

Intervention Arm

ACTIVE COMPARATOR

ablation of areas of fragmented signal in the right ventricular outflow tract plus continued implanted cardioverter defibrillator therapy

Procedure: Catheter Ablation

Single Cross Over Arm

OTHER

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

Interventions

Catheter Ablation PROCEDURE

catheter ablation of fragmented signal in the right ventricular outflow tract

Intervention Arm; Single Cross Over Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pacific Rim Electrophysiology Research Institute: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator

Study Sites (6)

Academic Medical Center, University of Amsterdam

Amsterdam, Netherlands

Location

Bhumipol Adulyadej Hospital, Royal Thai Air Force

Bangkok, Thailand

Location

Chulalongkorn University

Bangkok, Thailand

Location

Pacific Rim Electrophysiology Research Institute Data Coordinating Center

Bangkok, Thailand

Location

Ramathibodi Hospital

Bangkok, Thailand

Location

Chiang Mai University

Chiang Mai, Thailand

Location

Related 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.

  PMID: 26516000 BACKGROUND

• 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.

  PMID: 21403098 BACKGROUND

• 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.

  PMID: 26480928 BACKGROUND

• 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.

  PMID: 26671932 BACKGROUND

MeSH Terms

Conditions

Brugada Syndrome; Death

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Koonlawee Nademanee, MD

  Pacific Rim Electrophysiology Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2016
• First Posted: March 10, 2016
• Study Start: July 1, 2016
• Primary Completion: November 13, 2024
• Study Completion: November 13, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); TH (5)