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Completed

NCT Number: NCT07149545

Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial

The DEEP-PFA trial is an investigator-initiated, prospective, single-center, three-arm (1: 1: 1), randomized controlled study comparing three anesthesia regimens-midazolam + fentanyl (DS1), flurbiprofen + midazolam + fentanyl (DS2), and dexmedetomidine + midazolam + fentanyl (DS3)-for non-airway-assisted pulsed-field ablation (PFA) in atrial fibrillation (AF). Patients scheduled for atrial fibrillation ablation at Beijing Anzhen Hospital will be screened for eligibility. Following signature of informed consent, patients who meets all inclusion criteria without any exclusion criteria, will be randomly assigned at a 1:1:1 ratio to one of three groups: (1) DS1: Traditional Midazolam Group (Midazolam + Fentanyl); (2) DS2: Enhanced Analgesia Group (Flurbiprofen + Midazolam + Fentanyl); or (3) DS3: Enhanced Sedation Group (Dexmedetomidine + Midazolam + Fentanyl). The primary endpoint of this study was the proportion of patients achieving a Ramsay sedation score of ≥3 at the start of ablation.

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Deep Sedation Heart Diseases PFA Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 18-80 years
  • Diagnosis of paroxysmal or persistent atrial fibrillation with clinical indication for catheter ablation
  • Planned use of PFA as the ablation strategy
  • Ability and willingness to provide written informed consent

Exclusion criteria

  • Known hypersensitivity or allergy to study medications (fentanyl, midazolam, dexmedetomidine, flurbiprofen axetil)
  • Heart failure NYHA class III-IV
  • Severe obstructive sleep apnea syndrome
  • Severe respiratory disease, significant hepatic or renal dysfunction, advanced malignancy, or comorbidities with expected survival <1 year
  • Pregnancy or breastfeeding
  • Refusal to participate
  • Other circumstances deemed unsuitable for participation by the investigator

Treatment and study plan

Arm A (Fentanyl + Midazolam)

Drug

Prior to venous puncture, administer 0.5 mg midazolam intravenously, concurrently with 20 µg fentanyl intravenously. Subsequently, maintain fentanyl infusion at 1-1.5 µg/kg/h. Prior to atrial septal puncture, administer an additional 0.5 mg midazolam. Upon initiation of ablation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, supplement with 0.5 mg midazolam or 2 ml fentanyl.

Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)

Drug

Prior to venous puncture, administer 0.5 mg midazolam intravenously, followed by 20 µg fentanyl intravenously. Subsequently, maintain fentanyl infusion at 1-1.5 µg/kg/h. Prior to atrial septal puncture, administer 50-100 mg flurbiprofen ester and 0.5 mg midazolam. Upon ablation initiation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, supplement with 0.5 mg midazolam or 2 ml fentanyl.

Arm C (Fentanyl + Dexmedetomidine)

Drug

Prior to venous puncture, administer dexmedetomidine intravenously at 1 µg/kg/h for 15 minutes, then reduce to 0.4 µg/kg/h. Concurrently, administer fentanyl intravenously at 20 µg. Subsequently, maintain dexmedetomidine infusion at 1-1.5 µg/kg/h. After ablation initiation, adjust the fentanyl infusion rate to 2.0-2.5 µg/kg/h. If required during ablation, administer an additional 0.5 mg midazolam or 2 ml fentanyl.

Primary outcomes

  1. Proportion of patients with successful sedation at the start of ablation

    Time frame: At the initiation of ablation

    The primary endpoint of this study was the proportion of patients achieving a Ramsay sedation score of ≥3 at the initiation of ablation. The Ramsay sedation scale is as follows: 1 indicates restlessness; 2 indicates fully awake, quiet, and cooperative; 3 indicates drowsy but responsive to verbal commands; 4 indicates lightly asleep but responsive to touch or pain; 5 indicates asleep but slowly responsive to touch or pain; and 6 indicates deeply asleep with no response.

Secondary outcomes

  1. Incidence of hypotension

    Time frame: Perioperative period

    Defined as a mean arterial pressure (MAP) <65 mmHg or a ≥20% reduction from baseline.

  2. Incidence of hypoxemia

    Time frame: perioperative period

    Defined as SpO₂ <90% lasting for over 10 s.

  3. Number of intraoperative interventions

    Time frame: perioperative period

    Number of intraoperative interventions (oxygen adjustment, hemodynamic drugs, airway management, conversion to general anesthesia)

  4. Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).

    Time frame: Perioperative period

    Rated by the operating electrophysiologist on a 5-point Likert scale (1 = not difficult, 2 = mildly difficult, 3 = moderately difficult, 4 = very difficult, 5 = extremely difficult).

  5. Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).

    Time frame: perioperative period

    Operator satisfaction (5-point Likert scale): Rated postoperatively by the operating electrophysiologist on a 5-point Likert scale (1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied).

  6. Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain).

    Time frame: perioperative period

    Intraoperative pain intensity: Measured postoperatively based on patient recall using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst imaginable pain).

Sponsors and collaborators

Lead sponsor

Beijing Anzhen Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 2, 2025
Registry last updated
Feb 11, 2026

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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