Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters

Launched by THE THIRD PEOPLE'S HOSPITAL OF CHENGDU · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a treatment called ultra-high power ablation for patients with a heart condition known as atrial fibrillation, which causes irregular heartbeats. The study aims to understand the potential risks, specifically looking at injuries that might occur to the esophagus (the tube that connects your mouth to your stomach) during the procedure. Researchers will monitor various factors during the surgery, like how much energy is used and how long the procedure takes, to see how these might influence the risk of injury. This information will help improve the safety and effectiveness of the treatment.

To participate in the trial, patients need to be between 18 and 80 years old and diagnosed with a specific type of atrial fibrillation that hasn’t responded to medication. They should also be able to understand the study and give their consent. If someone joins the study, they can expect to undergo the ultra-high power ablation procedure and be monitored for any complications afterward. The study is currently not recruiting, so it’s still in the planning stages.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients aged between 18 and 80 years old.
• • 2. Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.
• • 3. Non-valvular atrial fibrillation.
• • 4. Able to understand the purpose of the study, voluntarily participate in this research, and the patient or their legal representative signs the informed consent form, willing to complete follow-ups as required by the protocol.
• Exclusion Criteria:
• • 1. Atrial fibrillation secondary to thyroid disease or other reversible factors;
• • 2. Imaging studies indicating intracardiac thrombus;
• • 3. Moderate to severe mitral stenosis or regurgitation;
• • 4. Left ventricular ejection fraction \<40%, or New York Heart Association (NYHA) functional class III or IV;
• • 5. Unstable angina;
• • 6. Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
• • 7. Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
• • 8. Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
• • 9. Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
• • 10. Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
• • 11. Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
• • 12. Conditions affecting vascular access;
• • 13. Patients who are concurrently participating in other drug or device clinical trials;
• • 14. Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.