Machine learning prediction of outcome following pulsed-field atrial fibrillation ablation: patient selection and risk factors.
Matteo Anselmino, Stefano Bianchi, Raffele De Lucia...
https://pubmed.ncbi.nlm.nih.gov/42134812Actively Recruiting
All Genders
ID05617456
Advanced Technologies For Successful Ablation of Atrial Fibrillation in Clinical Practice: ATHENA Study
Led by Giulio Zucchelli · Updated on 2022-11-15
4100
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Atrial fibrillation (AF) is the most common heart rhythm disorder worldwide, affecting about 3% of adults and expected to increase due to longer lifespans and more diagnoses. This study aims to prospectively evaluate a large group of patients undergoing AF ablation to identify clinical and procedural factors that predict success in preventing arrhythmia recurrence over the medium to long term. The main goal is to determine which parameters best predict freedom from clinical atrial arrhythmias 12 months after the procedure. Patients with indications for AF ablation will receive treatment following standard care at participating centers. The study collects data on procedural success immediately after ablation and tracks patients for 12 months to monitor for arrhythmia recurrence, other atrial arrhythmias, and any adverse events. The study will also assess patient-reported outcomes, ECG changes before and after ablation, and healthcare resource use. This observational study enrolls consecutive patients meeting eligibility criteria without altering their treatment plan. Participants will be followed for 12 months after their ablation procedure, with data collected on clinical history, drug therapy, arrhythmia recurrences, adverse events, and patient symptoms. Evaluations include acute procedural success, ECG monitoring, and questionnaires on quality of life and symptom severity. Researchers will analyze these data to identify factors associated with long-term success and safety of AF ablation. This study provides real-world insights into the management and outcomes of patients undergoing AF ablation over time.
CONDITIONS
Brief Title
Advanced TecHnologies For SuccEssful AblatioN of AF in Clinical Practice
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with an indication for atrial fibrillation ablation based on current international and local guidelines or physician discretion
- Patients willing and able to provide informed consent and participate in all testing at an approved clinical center
- Patients aged 18 years or older and legally able to give informed consent
You will not qualify if you...
- Patients enrolled in another investigational study or registry that interferes with this study, except mandatory governmental or purely observational registries
- Patients unwilling or unable to sign authorization for use of health information or informed consent
- Patients unavailable or unwilling to complete follow-up visits and examinations during the study
- Patients with a life expectancy of 12 months or less based on physician judgment
- Patients with unresolved adverse events from previous invasive procedures
- Women of childbearing potential who are or plan to become pregnant during the study
- Patients with left atrial thrombus detected within 4 weeks before the ablation procedure
- Patients with atrial fibrillation caused by electrolyte imbalance, thyroid disease, or reversible non-cardiac causes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Procedure
Duration - Day of procedure
Participants undergo atrial fibrillation ablation following standard care procedures.
1 visit (in-person)
Post-procedure Recovery
Duration - 7 days after the procedure
Participants are observed for acute procedural success and immediate adverse events after the ablation.
1 follow-up visit (in-person)
Long-term Monitoring
Duration - Up to 12 months
Participants are monitored to evaluate recurrence of atrial arrhythmias, adverse events, and patient-reported outcomes over time.
Periodic visits as per standard of care
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Actively Recruiting
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Research Team
G
Giulio Zucchelli, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Published Research Related To This Trial
Pulsed field ablation for atrial fibrillation in patients with heart failure: insight from the ATHENA registrys.
Marco Schiavone, Francesco Solimene, Antonio Dello Russo...
https://pubmed.ncbi.nlm.nih.gov/41910215De Novo Pulmonary Vein Isolation by Means of Pulsed Field Versus Conventional Thermal Ablation of Paroxysmal Atrial Fibrillation in Women: Safety, Efficiency, and Efficacy.
Valentina Ribatti, Antonio Dello Russo, Stefania Riva...
https://pubmed.ncbi.nlm.nih.gov/41676924Termination of atrial arrhythmia and restoration of sinus rhythm during pulsed field ablation with a pentaspline catheter in patients with persistent atrial fibrillation.
Massimo Moltrasio, Saverio Iacopino, Francesco Solimene...
https://pubmed.ncbi.nlm.nih.gov/40624924Does Age Impact Safety and Efficacy During Pulse-Field Ablation for Atrial Fibrillation?
Antonio Dello Russo, Claudio Tondo, Stefano Bianchi...
https://pubmed.ncbi.nlm.nih.gov/40265595Insight Into Early Recurrences After Pulsed-Field Ablation for Atrial Fibrillation: Results From a Multicenter Experience.
Antonio Bisignani, Francesco Solimene, Saverio Iacopino...
https://pubmed.ncbi.nlm.nih.gov/40190033National workflow experience with pulsed field ablation for atrial fibrillation: learning curve, efficiency, and safety.
Antonio Bisignani, Marco Schiavone, Francesco Solimene...
https://pubmed.ncbi.nlm.nih.gov/38814525Sedation strategies for pulsed-field ablation of atrial fibrillation: focus on deep sedation with intravenous ketamine in spontaneous respiration.
Saverio Iacopino, Jacopo Colella, Daniele Dini...
https://pubmed.ncbi.nlm.nih.gov/37494101