Atrial FibrillationNCT03836092
ECGI in Patients With Persistent Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Pacific Rim Electrophysiology Research Institute at 1 site in Thailand.
Trial summary
To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Radiofrequency ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- 23 Feb 2018to 1 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Atrial Fibrillation
- Being tested
- Radiofrequency ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablationProcedure or surgery
RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation
termination via ablation from atrial fibrillation during follow up period
Measured: 1 year
Secondary outcomes (1)
termination via ablation from atrial fibrillation during procedure
Termination of AF to NSR during procedure
Measured: over 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start23 Feb 2018
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pacific Rim Electrophysiology Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koonlawee Nademanee, MD, Pacific Rim Electrophysiology Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836092
- Sponsor's protocol ID
- PACIFICRERI3
- Status last verified
- Apr 2022
- First submitted
- 27 Jan 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 15172410Haissaguerre 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.
PubMed 25028391Conti 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.
PubMed 29759610Oketani 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.
PubMed 27374307Nademanee 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.
PubMed 25257091
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of AF Triggers, Initiators and Perpetuators by Electro Cardio-Graphic Imaging (ECGI) in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03836092
- Acronym / sponsor ID
- PACIFICRERI3
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Pacific Rim Electrophysiology Research InstituteUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the values and limitations of ECGI in guiding ablation and risk stratification in patients with persistent atrial fibrillation.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will include symptomatic persistent AF patients (N=50). The total of fifty patients will be studied.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency ablationRF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes). | Procedure or surgery | – |
Primary outcome
Freedom from Atrial Fibrillation
Time frame: 1 year
termination via ablation from atrial fibrillation during follow up period
1 secondary outcome
termination via ablation from atrial fibrillation during procedure
Time frame: over 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Results publication: PubMed 15172410Nademanee 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.
- Results publication: PubMed 25028391Haissaguerre 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.
- Results publication: PubMed 29759610Conti 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.
- Results publication: PubMed 27374307Oketani 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.
- Results publication: PubMed 25257091Nademanee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Pacific Rim Electrophysiology Research Institute at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03836092, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.