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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03764592
Other study ID # PACIFICReri2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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