- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03836092
ECGI in Patients With Persistent Atrial Fibrillation
April 9, 2022 updated by: Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute
Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation
To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied to determine:
- The values and limitations of ECGI in identifying atrial fibrillation (AF) triggers, AF initiators and AF perpetuators as targets sites for catheter ablations in patients with persistent AF.
- The mechanisms of residual atrial tachycardia/flutter (Res-AT/AFl) after AF substrate ablations by targeting complex fractionated atrial electrograms (CFAE).
- If there is a relationship between primary CFAE sites and driver sites or other distinct patterns from the ECGI mapping system.
- The rate of AF termination to sinus rhythm after ablation at target sites identified by ECGI
Study Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand
- Bumrungrad International Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patient population will include symptomatic persistent AF patients (N=50).
The total of fifty patients will be studied.
Description
Inclusion Criteria:
- Patients are diagnosed as persistent AF. Persistent AF was defined as continuous AF from 7 days to 12 months and long- lasting AF beyond twelve months.
- Patients who are symptomatic
- Patients who are willing to sign consent and be followed post procedure in an out- patient arrhythmia clinic
Exclusion Criteria:
- Patients under 18 years or over 85 years of age.
- Patients with chronic alcoholism.
- Recent myocardial infarction within one month of the study.
- Significant debilitating diseases or a terminal disease.
- Patients with documented left atrial thrombus.
- Medical or mental conditions precluding a long-term follow-up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Freedom from Atrial Fibrillation
Time Frame: 1 year
|
termination via ablation from atrial fibrillation during follow up period
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
termination via ablation from atrial fibrillation during procedure
Time Frame: over 6 months
|
Termination of AF to NSR during procedure
|
over 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Nademanee K, McKenzie J, Kosar E, Schwab M, Sunsaneewitayakul B, Vasavakul T, Khunnawat C, Ngarmukos T. A new approach for catheter ablation of atrial fibrillation: mapping of the electrophysiologic substrate. J Am Coll Cardiol. 2004 Jun 2;43(11):2044-53. doi: 10.1016/j.jacc.2003.12.054.
- Haissaguerre M, Hocini M, Denis A, Shah AJ, Komatsu Y, Yamashita S, Daly M, Amraoui S, Zellerhoff S, Picat MQ, Quotb A, Jesel L, Lim H, Ploux S, Bordachar P, Attuel G, Meillet V, Ritter P, Derval N, Sacher F, Bernus O, Cochet H, Jais P, Dubois R. Driver domains in persistent atrial fibrillation. Circulation. 2014 Aug 12;130(7):530-8. doi: 10.1161/CIRCULATIONAHA.113.005421. Epub 2014 Jul 15.
- Conti S, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P, Verma A. Effect of Different Cutpoints for Defining Success Post-Catheter Ablation for Persistent Atrial Fibrillation: A Substudy of the STAR AF II Trial. JACC Clin Electrophysiol. 2017 May;3(5):522-523. doi: 10.1016/j.jacep.2016.12.006. Epub 2017 May 15. No abstract available.
- Oketani N, Seitz J, Salazar M, Pisapia A, Kalifa J, Smit JJ, Nademanee K. Ablation of complex fractionated electrograms is useful for catheter ablation of persistent atrial fibrillation: Protagonist point of view. Heart Rhythm. 2016 Oct;13(10):2098-100. doi: 10.1016/j.hrthm.2016.06.036. Epub 2016 Jul 1. No abstract available.
- Nademanee K, Amnueypol M, Lee F, Drew CM, Suwannasri W, Schwab MC, Veerakul G. Benefits and risks of catheter ablation in elderly patients with atrial fibrillation. Heart Rhythm. 2015 Jan;12(1):44-51. doi: 10.1016/j.hrthm.2014.09.049. Epub 2014 Oct 11.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 23, 2018
Primary Completion (ACTUAL)
January 1, 2022
Study Completion (ACTUAL)
April 1, 2022
Study Registration Dates
First Submitted
January 27, 2019
First Submitted That Met QC Criteria
February 7, 2019
First Posted (ACTUAL)
February 11, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 9, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PACIFICRERI3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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