VF Mapping in Brugada and Early Repolarization Syndromes

NCT03764592 | Completed

• 1 other identifier: PACIFICReri2
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Brugada Syndrome; Early Repolarization Syndrome

Outcome Measures

Primary Outcomes (1)

• VF death

  ventricular fibrillation

  3 years

Study Arms (1)

VF BrS/ERS patients

Only patients that diagnosed with BrS or ERS based on ECG criteria

Other: radiofrequency ablation

Interventions

radiofrequency ablation OTHER

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

VF BrS/ERS patients

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Brugada marker or early repolarization marker on ECG.

You may qualify if:

• 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.•

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacific Rim Electrophysiology Research Institute: lead
• University of Bordeaux: collaborator

Study Sites (2)

Bumrungrad International Hospital

Bangkok, Thailand

Location

Pacific Rim Electrophysiology Research Institute Data Coordinating Center

Bangkok, 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 RESULT

• 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.

  PMID: 27979714 RESULT

• 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 RESULT

• 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.

  PMID: 27544747 RESULT

MeSH Terms

Conditions

Brugada Syndrome

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

• Koonlawee Nademanee, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: February 23, 2018
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)