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NCT Number: NCT06836999

Deep Sedation in Catheter Ablation of Atrial Fibrillation

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation, Paroxysmal or Persistent Cardiovascular Diseases Conscious Sedation Deep Sedations Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

deep sedation

Procedure

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.

Conscious Sedation

Procedure

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Score of patients' intraprocedural experiences

    Time frame: during the CA procedure

    Questionnaires for patient：QoR-40 and Likelihood to recommend (LTR).

  2. Score of ablators', staffs',nurse's intraprocedural experiences

    Time frame: during the CA procedure

    Likelihood to recommend (LTR) Questionnaire

  3. 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

  4. Rate of re-ablation acceptances

    Time frame: 4-12month post-ablation

    Rate of re-ablation acceptances if AF/AT recurrences.

  5. Procedure time

    Time frame: during the CA procedure

    Procedure time (skin to skin), fluoroscopy, ablation time, etc.

  6. The dosage of painkillers

    Time frame: during the CA procedure

    The dosage of painkillers

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Chengming Ma, MD

CONTACT

[email protected]

+86 18098875759

Yunlong Xia, Ph.D

CONTACT

[email protected]

+86 18098875555

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Dalian Medical University

Other

Registry information

Official study title

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

Acronym: PRIORI-AF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Mar 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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