- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03764592
VF Mapping in Brugada and Early Repolarization Syndromes
Mapping of Ventricular Fibrillation (VF) Substrates and VF Arrhythmogenic Sources/Reentrant Circuits in Patients With Brugada and Early Repolarization Syndromes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Carla Drew, BS
- Phone Number: 13104302613
- Email: carla@pacificrimep.com
Study Contact Backup
- Name: Koonlawee Nademanee, MD
- Phone Number: 66870708787
- Email: wee@pacificrimep.com
Study Locations
-
-
-
Bangkok, Thailand
- Recruiting
- Pacific Rim Electrophysiology Research Institute Data Coordinating Center
-
Contact:
- Koonlawee Nademanee, MD
- Phone Number: 66870708787
- Email: koonlawee@pacificrimep.com
-
Principal Investigator:
- Koonlawee Nademanee, MD
-
Bangkok, Thailand
- Recruiting
- Bumrungrad International Hospital
-
Principal Investigator:
- Koonlawee Nademanee, MD
-
Contact:
- Koonlawee Nademanee, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
VF BrS/ERS patients
Only patients that diagnosed with BrS or ERS based on ECG criteria
|
Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VF death
Time Frame: 3 years
|
ventricular fibrillation
|
3 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Koonlawee Nademanee, MD, Chulalongkorn University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PACIFICReri2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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