• Deep Sedation vs. General Anesthesia for Pulsed Field Ablation in Atrial Fibrillation

  NCT07621432

  Not yet recruitingInterventionalNot ApplicableUpdated Jun 2, 2026
• Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation

  NCT07541339

  Not yet recruitingInterventionalNot ApplicableUpdated Apr 21, 2026
• The Deep Sedation for Ablation Study

  NCT03844841

  CompletedInterventionalPhase 4Updated Jan 25, 2021
• Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial

  NCT07149545

  CompletedInterventionalNot ApplicableUpdated Feb 11, 2026
• Safety And FEasibility of a Simplified Deep Sedation Protocol for Pulsed-Field Ablation

  NCT07633548

  Enrolling by invitationObservationalUpdated Jun 8, 2026
• Feasibility of Pulsed Field Ablation Under Mild Conscious Sedation

  NCT06014814

  CompletedObservationalUpdated Nov 4, 2024

ClinicalTrials.gov ID

NCT06836999

Lead Sponsor

The First Affiliated Hospital of Dalian Medical UniversityOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

1,334Estimated

Last Update Posted

Mar 4, 2025Actual

Start Date

Mar 3, 2025Estimated

Primary Completion Date

Jul 31, 2027Estimated

Completion Date

Dec 31, 2027Estimated

Official Title

Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation

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.

• Atrial Fibrillation
• Atrial Fibrillation, Paroxysmal or Persistent
• Deep Sedations
• Conscious Sedation

• deep sedation
• Conscious sedation

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

The First Affiliated Hospital of Dalian Medical UniversityOTHER

13725265686@139.com+86 13725265686

13809000791@139.com+86 13809000791

17669657168@wo.cn+86 17669657168