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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Third People's Hospital of Chengdu

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Patients aged between 18 and 80 years old.

Diagnosed with drug-refractory, symptomatic, paroxysmal atrial fibrillation.

Non-valvular atrial fibrillation.

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.

Disqualifiers

Atrial fibrillation secondary to thyroid disease or other reversible factors;

Imaging studies indicating intracardiac thrombus;

Moderate to severe mitral stenosis or regurgitation;

Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;

Trial design

Design model

Parallel

Treatments tested in this trial

  • The ultra-high-power ablation group

    Procedure/Surgery

    The ultra-high-power ablation group will use the QDOT ablation catheter with a power of 90W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g. The cold saline flow rate during ablation is 8ml/min, and the ablation device will adjust power and saline flow rate based on the electrode temperature at the tip of the QDOT ablation catheter. The target temperature is 60°C, and the cut-off temperature is 65°C, with an ablation endpoint of 4 seconds.

  • The high-power ablation group

    Procedure/Surgery

    The high-power ablation group will use the STSF ablation catheter with a power of 50W, ablation points at site 3, inter-point distance maintained at 4-5mm, pressure maintained at 5-30g, and a cold saline flow rate of 15ml/min during ablation. The ablation endpoint for the posterior wall of the left atrium is an Ablation Index (AI) value of 360-410, for the anterior wall 450-480, and for the bottom and top of the left atrium 420-450.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Ultra-High-Power Ablation GroupExperimental treatment 1 intervention
Group B: High-Power Ablation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C

The number of times the esophageal temperature monitoring electrode shows a temperature exceeding 38.5°C

Time frame
Intraoperative Immediate

Secondary outcomes

1

The number of times Intraoperative steam POP occurrence

The number of times Intraoperative steam POP occurrence

Time frame
Intraoperative Immediate

Other outcomes

1

Whether esophageal injury and related complications such as esophageal fistula occur within one month postoperatively

Time frame
1 Months Post-Operation
2

Occurrence of chronic pericardial and POP-related complications within 7 days postoperatively

Occurrence of chronic pericardial and POP-related complications within 7 days postoperatively

Time frame
7 days Post-Operation.

Locations

This trial has no locations.

Sponsors and contacts

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