Clinical trial NCT06699368: Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters
Official title: Clinical Study on the Risk of Left Atrial POP Ablation and Esophageal Injury Under Ultra-High Power and Related Influencing Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation
Keywords: Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation
Lead sponsor: The Third People's Hospital of Chengdu
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.

Detailed description: This study aims to evaluate the risks of steam pop (POP) and esophageal injury, as well as related influencing parameters, under ultra-high power ablation technology. In the treatment of arrhythmias such as atrial fibrillation, cardiac ablation surgery is a common method. The use of ultra-high power ablation technology can shorten the operation time and improve effectiveness, but it may also increase the risk of damage to surrounding structures such as the esophagus. We will recruit a certain number of patients who are scheduled to undergo ultra-high power ablation surgery. We will record various parameters during the surgery, such as energy, time, and contact force, and monitor patients for signs of esophageal injury after the surgery. We expect that through this study, we can better understand the potential risks of ultra-high power ablation to the esophagus and identify the key parameters affecting these risks. This will help to improve surgical techniques, reduce complications, and enhance patient safety and surgical outcomes.

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.

Primary outcomes:
measure: The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C
timeFrame: Intraoperative Immediate
Secondary outcomes:
measure: The number of times Intraoperative steam POP occurrence
timeFrame: Intraoperative Immediate
Other outcomes:
measure: Whether esophageal injury and related complications such as esophageal fistula occur within one month postoperatively
timeFrame: 1 Months Post-Operation
measure: Occurrence of chronic pericardial and POP-related complications within 7 days postoperatively
timeFrame: 7 days Post-Operation.
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