NCT06836999Not yet recruiting
Deep Sedation in Catheter Ablation of Atrial Fibrillation
Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
Source: ClinicalTrials.gov · Last updated 4 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1334 (estimated)
- First submitted
- 16 Feb 2025
- Start date
- 3 Mar 2025
- Primary completion date
- 31 Jul 2027
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Diseases
- Atrial fibrillation
- NCT number
- NCT06836999
What you commit to
- Study type: Interventional
- Planned participants: 1334
- From 3 Mar 2025 to the primary completion date, 31 Jul 2027
- 16 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- has received CA procedure for AF or atrial septal defect repair before enrollment
- those who have participated in other clinical drug trials within 3 months prior to enrollment
Other illness
- left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack \[TIA\])
- acute or severe systemic infection
- those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
Lab values
- eGFR\<30mL/min/1.73㎡
- 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
Other
- 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
- 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, 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.).
Who the study is looking for
- ● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (16)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Guangdong Provincial People's Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Nanfang Hospital Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Anhui Provincial Hospital Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| The Second Affiliated Hospital of Nanchang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| The First Affiliated Hospital of NanChang University Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Jiangsu Provincial Hospital Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The Affiliated Hospital Of Medical School Of Ningbo University Coordinator of this site? Confirm its status | Ningbo | China | Unknown status |
| QingDao Municipal Hospital Coordinator of this site? Confirm its status | Qingdao | China | Unknown status |
| Shanghai East Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| The First Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
| Shanxi Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.