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

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.

Inclusion criteria:

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

Exclusion criteria:

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