Deep Sedation in Catheter Ablation of Atrial Fibrillation (NCT06836999) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Deep Sedation in Catheter Ablation of Atrial Fibrillation
China1,334 participantsStarted 2025-03-03
Plain-language summary
The current practice of anesthesia for atrial fibrillation catheter ablation (CA) procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rhythm outcomes
Timeframe: 4-12month post-ablation
Trial details
NCT IDNCT06836999
SponsorThe First Affiliated Hospital of Dalian Medical University