Deep Sedation in Catheter Ablation of Atrial Fibrillation
Launched by THE FIRST AFFILIATED HOSPITAL OF DALIAN MEDICAL UNIVERSITY · Feb 16, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effects of deep sedation during a procedure called catheter ablation, which is used to treat atrial fibrillation (AF), a condition where the heart beats irregularly. The trial aims to find out if deep sedation offers more benefits than other types of sedation, such as conscious sedation, especially in terms of pain relief, safety during the procedure, and long-term heart rhythm outcomes. Researchers want to gather information from patients, doctors, and lab staff to see how everyone experiences the procedure under deep sedation.
To participate in this trial, you should be between 18 and 75 years old and diagnosed with atrial fibrillation, whether it's paroxysmal (intermittent) or persistent (ongoing). However, certain health conditions may exclude you from joining, such as severe heart issues, recent strokes, or if you are pregnant. If eligible, you can expect to undergo the catheter ablation procedure while being monitored closely, and your experiences will help researchers understand the benefits of deep sedation better. The trial is not yet recruiting participants, so there's still time to learn more before deciding to join.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • ● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
- Exclusion Criteria:
- • has received CA procedure for AF or atrial septal defect repair before enrollment
- • left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
- • eGFR\<30mL/min/1.73㎡
- • a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \[TIA\])
- • acute or severe systemic infection
- • intolerant to sedation or with a history suggestive of sleep apnea
- • BMI \> 35 kg/㎡
- • has contraindications to procedural sedation or refused to participate in this trial
- • Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) \> 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g/L), or active bleeding
- • pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- • life expectancy \< 12 months
- • those who have participated in other clinical drug trials within 3 months prior to enrollment
- • those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
- • those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).
About The First Affiliated Hospital Of Dalian Medical University
The First Affiliated Hospital of Dalian Medical University is a leading healthcare institution dedicated to advancing medical research and clinical excellence. As a prominent academic medical center in Dalian, China, it integrates patient care, education, and innovative research to enhance health outcomes. The hospital is committed to conducting high-quality clinical trials that contribute to the scientific community and improve treatment options for patients. With a robust infrastructure and a multidisciplinary team of experts, it fosters collaboration and integrity in research, aiming to translate clinical findings into effective healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Qingdao, Shandong, China
Guangzhou, Guangdong, China
Shanghai, Shanghai, China
Dalian, Liaoning, China
Taiyuan, Shanxi, China
Guangzhou, Guangdong, China
Suzhou, Jiangsu, China
Nanchang, Jiangxi, China
Hefei, Anhui, China
Hangzhou, Zhejiang, China
Tianjin, Tianjin, China
Hefei, Anhui, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Tianjin, Tianjin, China
Hangzhou, Zhejiang, China
Ningbo, Zhejiang, China
Patients applied
Trial Officials
Yunlong Xia, Ph.D
Principal Investigator
The First Affiliated Hospital of Dalian Medical University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported