NCT07149545Completed
Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 240 (actual)
- First submitted
- 24 Aug 2025
- Start date
- 15 Oct 2025
- Primary completion date
- 27 Jan 2026
- Lead sponsor
- Beijing Anzhen Hospital
- Diseases
- Atrial fibrillation
- NCT number
- NCT07149545
What you commit to
- Study type: Interventional
- Participants enrolled: 240
- From 15 Oct 2025 to the primary completion date, 27 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- Pregnancy or breastfeeding
- Refusal to participate
- Other circumstances deemed unsuitable for participation by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.