Atrial FibrillationNCT04997824
Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
A study testing Artificial Intelligence-based atrial fibrillation catheter ablation and Medical Therapy in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial summary
Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of 1.7% of the total population in Korea, associated with 25% of ischemic stroke and 30% of heart failure, and is a major cardiovascular disease that doubles the risk of dementia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Artificial Intelligence-based atrial fibrillation catheter ablation and Medical Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2021to Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Left atrium size < 55 mm
- AF recurred during the administration of antiarrhythmic drugs or that antiarrhythmic drugs intolerable patients
- Patients eligible for anticoagulant therapy (to prevent thromboembolic events)
Who cannot join
- AF associated with severe cardiac anomalies or structural heart disease with hemodynamic influence
- Patients who have difficulty in CT imaging using a contrast medium
- Patients with active internal bleeding
- Inappropriate anticoagulant therapy
- Serious comorbidities
- Patients expected to survive less than 1 year
Show all 9Show fewer
- People with drug or alcohol addiction
- Those who cannot read the consent form (illiterate, foreigners, etc.)
- Patients who are judged unsuitable for participation in clinical research by the judgment of other investigators
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Hui-Nam Pak, v, hnpak@yuhs.ac
About this study
Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of 1.7% of the total population in Korea, associated with 25% of ischemic stroke and 30% of heart failure, and is a major cardiovascular disease that doubles the risk of dementia. AF catheter ablation (AFCA) is an effective procedure that lowers the risk of heart failure mortality and cerebral infarction and improves cognitive or renal functions. However, the recurrence rate after the procedure is relatively high, especially in patients with long-standing persistent AF in which atrial remodeling has already progressed. Research on the prediction of treatment efficacy using artificial intelligence (AI) is being actively conducted around the world. We predicted the AFCA poor responders who will progress to permanent AF despite AFCA among a total of 3,372 patients included in the Yonsei AF Ablation cohort and the 2nd independent cohort with a long-term follow-up through AI with area under curve (AUC) 0.943. Therefore, in this prospective randomized clinical study, the difference between the patient selection for AFCA using AI algorithm and the clinical guidelines-based decision will be compared and evaluated in terms of long-term rhythm outcome.
Read the detailed description
Study design
- Prospective randomization (AI-based patient selection group vs. conventional guidelines-based patient selection group)
- Target number of subjects 1000 patients (500 people in each group)
- Rhythm follow-up schedule: 2012 ACC/AHA/ESC guidelines (basal, 3 months, then every 6 months Holter, ECG when symptomatic)
- Anticoagulant therapy follows 2020 ESC guidelines.
- Evaluation of all adverse events occurring in each group and comparative evaluation of hospitalization rates, major cardiovascular attacks, and mortality
Process of Patient Selection A guideline-based appropriate candidate for AFCA Randomization for AI-guide group vs. Clinical guideline-based group Poor responder selection by AI at the outpatient clinic AI-prediction outcomes should be noticed in AI-guided groups, but not in the clinical guideline-based group.
Recommendation of rate control for AI-predicted poor responders All-comer ablation in guideline-based group
Progress and rhythm/ECG tracking
- Implemented according to 2012 American College of Cardiology(ACC)/American Heart Association(AHA)/Heart Rhythm Society(HRS) guidelines for AF management
- Outpatient follow-up 1 to 2 weeks after the start of the procedure or drug treatment
- Follow-up every 3 months after the procedure, and every 6 months thereafter
- If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time and follow the rhythm with a Holter or an event recorder.
- Conditions
- Atrial Fibrillation
- Being tested
- Artificial Intelligence-based atrial fibrillation catheter ablation, Medical Therapy
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence-based atrial fibrillation catheter ablationProcedure or surgery
- Patient selection for Atrial Fibrillation Catheter Ablation(AFCA)
- AI-guided prediction for poor responder of AFCA in the outpatient clinic
- Sharing information on the AI prediction with the patient and family member
- AFCA after consent to the procedure
- Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers
- Monitoring esophageal temperature
- Evaluation of Procedure and ablation time, and complication afer procedure
- Post-procedure rhythm follow-up is carried out according to the study design above.
Medical TherapyProcedure or surgery
- Patient selection for Atrial Fibrillation Catheter Ablation(AFCA)
- Decision for AFCA based on clinical guidelines and the experience of the attending physician
- AFCA after consent to the procedure
- Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers
- Monitoring esophageal temperature
- Evaluation of Procedure and ablation time, and complication afer procedure
| Study group | Role | What they receive |
|---|---|---|
| Artificial Intelligence-based atrial fibrillation catheter ablation | Experimental | catheter ablation Receives: Procedure: Artificial Intelligence-based atrial fibrillation catheter ablation |
| Medical Therapy | Active comparator | catheter ablation Receives: Procedure: Medical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)
Efficacy evaluation: Clinical recurrence rate - Defined as AF or atrial tachycardia lasting over 30 seconds after 3 months of procedure. Rhythm monitoring based on 2012 ACC/AHA/HRS guidelines as described above. 24-hour Holter ECG monitoring will be performed at 2-3 month and every 6 months within 2 years of procedure, Holter every 1 year after 2 years of procedure and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
Measured: Up to 5 years
safety of Atrial Fibrillation Catheter Ablation(AFCA)
Safety Assessment: Incidence of procedure-related complications within 30 days of procedure (thoracotomy, cerebral infarction, pericardial effusion or pericardial tamponade, inguinal puncture site hematoma, and vascular complications)
Measured: Up to 5 years
Secondary outcomes (5)
Comparison of procedure time, ablation time and hospitalization period
Measured: Immediate after procedure
Anti-arrhythmic drug or anticoagulation therapy related complication rate
Measured: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
Re-hospitalization rate of electrical cardioverson after the procedure
Measured: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
number of electrical cardioversion after the procedure
Measured: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Measured: Immediate after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start7 Oct 2021
- Primary completionJun 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Nam Pak, Principal investigator, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997824
- Sponsor's protocol ID
- 4-2021-0608
- Status last verified
- May 2023
- First submitted
- 19 Jul 2021
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
- ClinicalTrials.gov ID
- NCT04997824
- Acronym / sponsor ID
- 4-2021-0608
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 10 Aug 2021 (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.
Atrial fibrillation (AF) is a major cardiovascular disease with a prevalence of 1.7% of the total population in Korea, associated with 25% of ischemic stroke and 30% of heart failure, and is a major cardiovascular disease that doubles the risk of dementia. AF catheter ablation (AFCA) is an effective procedure that lowers the risk of heart failure mortality and cerebral infarction and improves cognitive or renal functions. However, the recurrence rate after the procedure is relatively high, especially in patients with long-standing persistent AF in which atrial remodeling has already progressed. Research on the prediction of treatment efficacy using artificial intelligence (AI) is being actively conducted around the world. We predicted the AFCA poor responders who will progress to permanent AF despite AFCA among a total of 3,372 patients included in the Yonsei AF Ablation cohort and the 2nd independent cohort with a long-term follow-up through AI with area under curve (AUC) 0.943. Therefore, in this prospective randomized clinical study, the difference between the patient selection for AFCA using AI algorithm and the clinical guidelines-based decision will be compared and evaluated in terms of long-term rhythm outcome.
Detailed description
Study design
- Prospective randomization (AI-based patient selection group vs. conventional guidelines-based patient selection group)
- Target number of subjects 1000 patients (500 people in each group)
- Rhythm follow-up schedule: 2012 ACC/AHA/ESC guidelines (basal, 3 months, then every 6 months Holter, ECG when symptomatic)
- Anticoagulant therapy follows 2020 ESC guidelines.
- Evaluation of all adverse events occurring in each group and comparative evaluation of hospitalization rates, major cardiovascular attacks, and mortality
Process of Patient Selection A guideline-based appropriate candidate for AFCA Randomization for AI-guide group vs. Clinical guideline-based group Poor responder selection by AI at the outpatient clinic AI-prediction outcomes should be noticed in AI-guided groups, but not in the clinical guideline-based group.
Recommendation of rate control for AI-predicted poor responders All-comer ablation in guideline-based group
Progress and rhythm/ECG tracking
- Implemented according to 2012 American College of Cardiology(ACC)/American Heart Association(AHA)/Heart Rhythm Society(HRS) guidelines for AF management
- Outpatient follow-up 1 to 2 weeks after the start of the procedure or drug treatment
- Follow-up every 3 months after the procedure, and every 6 months thereafter
- If the patient complains of arrhythmia symptoms, conduct an electrocardiogram at any time and follow the rhythm with a Holter or an event recorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence-based atrial fibrillation catheter ablation | Experimental | Procedure: Artificial Intelligence-based atrial fibrillation catheter ablationcatheter ablation |
| Medical Therapy | Active comparator | Procedure: Medical Therapycatheter ablation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Left atrium size < 55 mm
- AF recurred during the administration of antiarrhythmic drugs or that antiarrhythmic drugs intolerable patients
- Patients eligible for anticoagulant therapy (to prevent thromboembolic events)
Key exclusion criteria (9 listed)
- AF associated with severe cardiac anomalies or structural heart disease with hemodynamic influence
- Patients who have difficulty in CT imaging using a contrast medium
- Patients with active internal bleeding
- Inappropriate anticoagulant therapy
- Serious comorbidities
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 |
|---|---|---|
| Artificial Intelligence-based atrial fibrillation catheter ablation1. Patient selection for Atrial Fibrillation Catheter Ablation(AFCA) 2. AI-guided prediction for poor responder of AFCA in the outpatient clinic 3. Sharing information on the AI prediction with the patient and family member 4. AFCA after consent to the procedure 5. Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers 6. Monitoring esophageal temperature 7. Evaluation of Procedure and ablation time, and complication afer procedure 8. Post-procedure rhythm follow-up is carried out according to the study design above. | Procedure or surgery | Artificial Intelligence-based atrial fibrillation catheter ablation |
| Medical Therapy1. Patient selection for Atrial Fibrillation Catheter Ablation(AFCA) 2. Decision for AFCA based on clinical guidelines and the experience of the attending physician 3. AFCA after consent to the procedure 4. Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers 5. Monitoring esophageal temperature 6. Evaluation of Procedure and ablation time, and complication afer procedure | Procedure or surgery | Medical Therapy |
Primary outcome
Efficacy of Atrial Fibrillation Catheter Ablation(AFCA)
Time frame: Up to 5 years
Efficacy evaluation: Clinical recurrence rate - Defined as AF or atrial tachycardia lasting over 30 seconds after 3 months of procedure. Rhythm monitoring based on 2012 ACC/AHA/HRS guidelines as described above. 24-hour Holter ECG monitoring will be performed at 2-3 month and every 6 months within 2 years of procedure, Holter every 1 year after 2 years of procedure and ECG and monitoring with a Holter or an event recorder will be performed at any time if the patient complains of symptoms
safety of Atrial Fibrillation Catheter Ablation(AFCA)
Time frame: Up to 5 years
Safety Assessment: Incidence of procedure-related complications within 30 days of procedure (thoracotomy, cerebral infarction, pericardial effusion or pericardial tamponade, inguinal puncture site hematoma, and vascular complications)
5 secondary outcomes
Comparison of procedure time, ablation time and hospitalization period
Time frame: Immediate after procedure
Anti-arrhythmic drug or anticoagulation therapy related complication rate
Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
Re-hospitalization rate of electrical cardioverson after the procedure
Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
number of electrical cardioversion after the procedure
Time frame: 1 week, 3, 6, 12, 18, 24, 36 months after procedure
Major cardiovascular event rate - Death, myocardial infarction, coronary angioplasty, and re-hospitalization for arrhythmia and heart failure
Time frame: Immediate after procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
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CONVERGE Post-Approval Study (PAS)
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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Atrial Fibrillation (AF)
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.
Hui-Nam Pak principal investigator
Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence-based atrial fibrillation catheter ablation and Medical Therapy in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
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 9 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: looking for participants now, as of the sponsor's last update on 24 May 2023. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Nam Pak (82-2-2228-8459, hnpak@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Atrial Fibrillation Catheter Ablation(AFCA) (time frame: Up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2023.