Deep Sedation in Catheter Ablation of Atrial Fibrillation (PRIORI-AF)

The First Affiliated Hospital of Dalian Medical University

Status: Not yet enrolling

Conditions: Deep Sedations; Atrial Fibrillation; Conscious Sedation; Atrial Fibrillation, Paroxysmal or Persistent

Treatments: Procedure: deep sedation; Procedure: Conscious sedation

Study type: Interventional

Funder types: Other

Identifiers

NCT06836999

ChiCTR2500096790 (Other Identifier)

TEMP-000758

Details and patient eligibility

About

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.

Enrollment: 1,334 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,334 participants in 2 patient groups

DS group

Experimental group

Description:

The CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic

Treatment:

Procedure: deep sedation

CS group

Sham Comparator group

Description:

The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl.

Treatment:

Procedure: Conscious sedation