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

NCT07149545 | Completed

• 1 other identifier: KS2025277
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrial Fibrillation (AF); PFA; Deep Sedation

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with successful sedation at the start 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.

  At the initiation of ablation

Secondary Outcomes (6)

• Incidence of hypotension

  Perioperative period

• Incidence of hypoxemia

  perioperative period

• Number of intraoperative interventions

  perioperative period

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

  Perioperative period

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

  perioperative period

Study Arms (3)

Arm A (Fentanyl + Midazolam)

EXPERIMENTAL

After venipuncture, patients receive intravenous midazolam 0.5 mg and fentanyl 20 µg, followed by continuous fentanyl infusion at 1-1.5 µg/kg/h. An additional 0.5 mg of midazolam is administered before interatrial septal puncture. After the start of ablation, fentanyl infusion is increased to 2.0-2.5 µg/kg/h. If needed, 0.5 mg of midazolam or 2 mL of fentanyl may be added.

Drug: Arm A (Fentanyl + Midazolam)

Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)

EXPERIMENTAL

After venipuncture, patients receive midazolam 0.5 mg and fentanyl 20 µg intravenously, followed by a fentanyl infusion at 1-1.5 µg/kg/h. Prior to septal puncture, patients receive flurbiprofen axetil 50-100 mg and an additional 0.5 mg of midazolam. After ablation begins, fentanyl infusion is increased to 2.0-2.5 µg/kg/h. If needed, 0.5 mg of midazolam or 2 mL of fentanyl may be added.

Drug: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)

Arm C (Fentanyl + Dexmedetomidine)

EXPERIMENTAL

Following femoral venous access, a loading dose of dexmedetomidine (1.0 µg/kg) was infused intravenously over 15 minutes. A maintenance infusion of 0.4 µg/kg/h was initiated thereafter (typically post-transseptal puncture). Fentanyl infusion commenced at venous access (1.0-1.5 µg/kg/h) and was increased to 2.0-2.5 µg/kg/h during ablation. Rescue boluses of midazolam (0.5 mg) or fentanyl (20-50 µg) were administered if required.

Drug: Arm C (Fentanyl + Dexmedetomidine)

Interventions

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 A (Fentanyl + Midazolam)

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 B (Flurbiprofen axetil + Fentanyl + Midazolam)

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.

Arm C (Fentanyl + Dexmedetomidine)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Fentanyl; Midazolam; flurbiprofen axetil; Dexmedetomidine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Imidazoles; Azoles

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2025
• First Posted: September 2, 2025
• Study Start: October 15, 2025
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)