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

NCT ID: NCT06699368

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-28
• Study Completion Date: 2025-06-05

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.

Conditions

Ultra-High Power Ablation,Safety of Atrial Fibrillation Ablation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ultra-High-Power Ablation Group

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.

Group Type: EXPERIMENTAL

The ultra-high-power ablation group

Intervention Type: PROCEDURE

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.

High-Power Ablation Group

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.

Group Type: ACTIVE_COMPARATOR

The high-power ablation group

Intervention Type: PROCEDURE

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.

Interventions

The ultra-high-power ablation group

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.

Intervention Type: PROCEDURE

The high-power ablation group

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Third People's Hospital of Chengdu

OTHER

Sponsor Role: lead

Responsible Party

Hanxiong Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Prof.Liu

Role: CONTACT

lhanx@126.com

8613551044286

Other Identifiers

CDSY-UHP-POP-ESO

Identifier Type: -

Identifier Source: org_study_id