NCT04997824Recruiting
Artificial Intelligence Guided Patient Selection for Atrial Fibrillation Catheter Ablation: Randomized Clinical Trial (AI-PAFA Trial)
Source: ClinicalTrials.gov · Last updated 24 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1000 (estimated)
- First submitted
- 19 Jul 2021
- Start date
- 7 Oct 2021
- Primary completion date
- Jun 2031
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT04997824
What you commit to
- Study type: Interventional
- Planned participants: 1000
- From 7 Oct 2021 to the primary completion date, Jun 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Inappropriate anticoagulant therapy
- People with drug or alcohol addiction
Other illness
- AF associated with severe cardiac anomalies or structural heart disease with hemodynamic influence
- Patients with active internal bleeding
Other
- Patients who have difficulty in CT imaging using a contrast medium
- Serious comorbidities
- Patients expected to survive less than 1 year
- 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
Who the study is looking for
- 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)
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.