Clinical trial NCT06836999: Deep Sedation in Catheter Ablation of Atrial Fibrillation
Official title: Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Atrial Fibrillation, Paroxysmal or Persistent
Deep Sedations
Conscious Sedation
Keywords: deep sedation
conscious sedation
catheter ablation
atrial fibrillation
Lead sponsor: The First Affiliated Hospital of Dalian Medical University
Sponsor class: OTHER
First posted: 2025-02-20
Enrollment: 1334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.).

Primary outcomes:
measure: Rhythm outcomes
timeFrame: 4-12month post-ablation
Secondary outcomes:
measure: Score of patients' intraprocedural experiences
timeFrame: during the CA procedure
measure: Score of ablators', staffs',nurse's intraprocedural experiences
timeFrame: during the CA procedure
measure: respiratory system safety outcome
timeFrame: From the start of sedation to the end of the procedure
measure: Rate of re-ablation acceptances
timeFrame: 4-12month post-ablation
measure: Procedure time
timeFrame: during the CA procedure
measure: The dosage of painkillers
timeFrame: during the CA procedure
measure: the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
timeFrame: From the start of sedation to the end of the procedure
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Provincial Hospital
state: Anhui
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: NanFang Hospital
state: Guangdong
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
city: Dalian
country: China
facility: First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine
state: Zhejiang
city: Ningbo
country: China
facility: The Affiliated Hospital Of Medical School Of Ningbo University
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Dalian Medical University
name: Yunlong Xia, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grimaldi M, Quadrini F, Caporusso N, Troisi F, Vitulano N, Delmonte V, Di Monaco A. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023 Aug 2;25(9):euad222. doi: 10.1093/europace/euad222.
citation: Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/