Actively Recruiting
Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Led by Yonsei University · Updated on 2023-05-24
1000
Participants Needed
1
Research Sites
503 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Left atrium size less than 55 mm
- Atrial fibrillation recurred during antiarrhythmic drug use or patient is intolerant to these drugs
- Eligible for anticoagulant therapy to prevent thromboembolic events
You will not qualify if you...
- Atrial fibrillation associated with severe cardiac anomalies or structural heart disease affecting hemodynamics
- Difficulty undergoing CT imaging with contrast medium
- Active internal bleeding
- Inappropriate anticoagulant therapy
- Serious comorbid conditions
- Expected survival less than 1 year
- Drug or alcohol addiction
- Unable to read the consent form (illiterate, foreigners, etc.)
- Judged unsuitable for clinical research participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
H
Hui-Nam Pak
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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