Clinical trial NCT02704416: Ablation in Brugada Syndrome for the Prevention of VF
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brugada Syndrome
Keywords: Ventricular arrhythmias
aborted cardiac arrest
cardiac death
Lead sponsor: Pacific Rim Electrophysiology Research Institute
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2016-03-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Freedom of Ventricular Fibrillation/Tachycardia Recurrences
timeFrame: 3 year followup
Secondary outcomes:
measure: Freedom without drug
timeFrame: 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center, University of Amsterdam
city: Bangkok
country: Thailand
facility: Bhumipol Adulyadej Hospital, Royal Thai Air Force
city: Bangkok
country: Thailand
facility: Chulalongkorn University
city: Bangkok
country: Thailand
facility: Pacific Rim Electrophysiology Research Institute Data Coordinating Center
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
Study officials:
affiliation: Pacific Rim Electrophysiology Research Institute
name: Koonlawee Nademanee, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.