Status:
NOT_YET_RECRUITING
Comparison of Three Deep Sedation Strategies for Pulsed-Field Ablation
Lead Sponsor:
Beijing Anzhen Hospital
Conditions:
Atrial Fibrillation (AF)
PFA
Eligibility:
All Genders
60+ years
Phase:
NA
Brief Summary
This prospective, randomized, parallel, single-center study aims to evaluate the effectiveness and safety of three deep sedation strategies in patients undergoing pulsed-field ablation (PFA) for atria...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Age ≥18 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
Exclusion
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07149545
Start Date
September 15 2025
End Date
October 30 2025
Last Update
September 2 2025
Active Locations (1)
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1
Beijing Anzhen Hospital
Beijing, China