VF Mapping in Brugada and Early Repolarization Syndromes

Brugada Syndrome Clinical Trial

Official title:

Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With Brugada and Early Repolarization Syndromes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764592
• Other study ID #: PACIFICReri2
• Status: Recruiting
• Start date: February 23, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Pacific Rim Electrophysiology Research Institute
• Contact: Carla Drew, BS
• Phone: 13104302613
• Email: carla[@]pacificrimep.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with BrS and Early Repolarization.

Description:

The investigators will study symptomatic BrS and ERs syndrome (N=25) and asymptomatic patients (N=25) age between 16-70 years old to determine values and limitations of non-invasive mapping using electrocardiographic imaging (ECGI) in identifying VF substrates as target sites for catheter ablations in patients with Brugada (BrS) and Early repolarization syndromes (ERS) and also determine the mechanisms of VF in BrS and ERs syndromes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

Inclusion Criteria:

Patients presenting with the type1 BrS ECG or ER ECG signature pattern, with/without a sodium channel blocker. Patients with the following one of these symptoms or arrhythmias will be considered as symptomatic patients: 1) aborted cardiac arrest cases, 2) documented VF episodes, 3) agonal respiration during sleep with difficulty to arouse, 4) syncope of unknown origin, or 5) seizure suspected of arrhythmic origin.•

Exclusion Criteria:

Patients who refuse informed consent and to participate to the best ability in the study.

Patients who have structural heart disease or concomitant medical illness.

Related Conditions & MeSH terms

• Brugada Syndrome
• Early Repolarization Syndrome
• Syndrome

Intervention

Other:
• radiofrequency ablation
Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.

Locations

Country	Name	City	State
Thailand	Bumrungrad International Hospital	Bangkok
Thailand	Pacific Rim Electrophysiology Research Institute Data Coordinating Center	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Pacific Rim Electrophysiology Research Institute	University of Bordeaux

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Nademanee K, Hocini M, Haissaguerre M. Epicardial substrate ablation for Brugada syndrome. Heart Rhythm. 2017 Mar;14(3):457-461. doi: 10.1016/j.hrthm.2016.12.001. Epub 2016 Dec 12. No abstract available. — View 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, Co — 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 righ — View Citation

Veerakul G, Nademanee K. Will we be able to cure brugada syndrome? Heart Rhythm. 2016 Nov;13(11):2159-2160. doi: 10.1016/j.hrthm.2016.08.025. Epub 2016 Aug 17. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VF death	ventricular fibrillation	3 years