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

February 27, 2025 updated by: The First Affiliated Hospital of Dalian Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1334

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230036
        • Anhui Provincial Hospital
        • Contact:
        • Contact:
          • Su Hao
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Nanfang Hospital
        • Contact:
        • Contact:
          • Yuegang Wang
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
        • Contact:
        • Contact:
          • Yumei Xue
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Provincial Hospital
        • Contact:
          • Minglong Chen
        • Contact:
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
        • Contact:
        • Contact:
          • Tingbo Jiang
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
        • Contact:
        • Contact:
          • Ran Yin
      • Nanchang, Jiangxi, China, 330008
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
          • Qi Chen
        • Contact:
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
    • Shandong
      • Qingdao, Shandong, China, 266011
        • Qingdao Municipal Hospital
        • Contact:
        • Contact:
          • Bingong Li
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Shanghai East Hospital
        • Contact:
        • Contact:
          • Zhigang Zhang
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Shanxi Cardiovascular Hospital
        • Contact:
        • Contact:
          • Haixiong Wang
    • Tianjin
      • Tianjin, Tianjin, China, 300050
        • Tianjin Medical University General Hospital
        • Contact:
        • Contact:
          • Heng Cai
      • Tianjin, Tianjin, China, 300010
        • Tianjin Chest Hospital
        • Contact:
        • Contact:
          • Fengmin Lu
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University
        • Contact:
        • Contact:
          • Yaping Wang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine
        • Contact:
        • Contact:
          • Xia Sheng
      • Ningbo, Zhejiang, China, 315211
        • The Affiliated Hospital Of Medical School Of Ningbo University
        • Contact:
          • Huimin Chu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DS group
The CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic
Procedure: deep sedation
The deep sedation was inducted using atropine 0.5 mg iv administered 15 min before the procedure to avoid aspiration. In the EP lab, anesthesia preparation is performed, including invasive arterial blood pressure monitoring via puncture of the radial artery or brachial artery. Noninvasive BP monitoring every 5 minutes is also permitted. Subsequently, midazolam 1-2mg or accompanied with propofol 0.3-0.5 mg/kg is administered intravenously at the start of the CA procedure (i.e., femoral vein puncture), and fentanyl 25 µg is administered intravenously. Then, continuous titrated infusion of propofol 0.2-0.5mg/kg/h for anesthesia maintenance throughout the CA procedure. An additional iv fentanyl (25-50 µg) is administrated at the beginning of RF applications. Further boluses or additional drugs are administrated as needed to maintain analgesia during the procedure. The anesthesiologist is responsible for administering anesthesia and administering medication.
Sham Comparator: CS group
The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl.
Procedure: Conscious sedation
This protocol is aimed at analgesia, with local infiltration of lidocaine for femoral vein puncture followed by intravenous administration of fentanyl (1-2 ug/kg/h). The operator determines the dose of fentanyl and midazolam. A midazolam 1-5 mg bolus is administrated before electrical cardioversion is performed or when the patient is nervous.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhythm outcomes
Time Frame: 4-12month post-ablation
The primary effectiveness endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month (9 months) after the procedure without taking I/III AADs. Patients who had to redo ablation or failed to discontinue I/III AADs after the blanking period are considered as primary endpoint
4-12month post-ablation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score of patients' intraprocedural experiences
Time Frame: during the CA procedure
Questionnaires for patient：QoR-40 and Likelihood to recommend (LTR).
during the CA procedure
Score of ablators', staffs',nurse's intraprocedural experiences
Time Frame: during the CA procedure
Likelihood to recommend (LTR) Questionnaire
during the CA procedure
Rate of re-ablation acceptances
Time Frame: 4-12month post-ablation
Rate of re-ablation acceptances if AF/AT recurrences.
4-12month post-ablation
Procedure time
Time Frame: during the CA procedure
Procedure time (skin to skin), fluoroscopy, ablation time, etc.
during the CA procedure
The dosage of painkillers
Time Frame: during the CA procedure
The dosage of painkillers
during the CA procedure
respiratory system safety outcome
Time Frame: From the start of sedation to the end of the procedure
the incidence of intraprocedural severe decrease in blood oxygenation (decrease in fingertip oxygen saturation to less than 90% or a >10% decrease in fingertip oxygen saturation from baseline)，apnea, respiratory depression, need for ventilator-assisted ventilation, and need for respiratory stimulant therapy
From the start of sedation to the end of the procedure
the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
Time Frame: From the start of sedation to the end of the procedure
the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
From the start of sedation to the end of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Dalian Medical University

Investigators

  • Principal Investigator: Yunlong Xia, Ph.D, The First Affiliated Hospital of Dalian Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 3, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 27, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEMP-000758
  • ChiCTR2500096790 (Other Identifier: Chinese clinical trial registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To protect the privacy of subjects, the study data can be accessed by requesting from the PI.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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