Atrial Fibrillation (AF)NCT07149545
Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial
A study testing Arm A (Fentanyl + Midazolam), Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) and Arm C (Fentanyl + Dexmedetomidine) in people with Atrial Fibrillation (AF) and PFA, run by Beijing Anzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (AF), PFA, Deep Sedation
- What is being tested?
- Arm A (Fentanyl + Midazolam), Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) and Arm C (Fentanyl + Dexmedetomidine)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to 27 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Arm A (Fentanyl + Midazolam), Arm B (Flurbiprofen axetil + Fentanyl + Midazolam), Arm C (Fentanyl + Dexmedetomidine)
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Arm C (Fentanyl + Dexmedetomidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the initiation of ablation
Secondary outcomes (6)
Incidence of hypotension
Defined as a mean arterial pressure (MAP) <65 mmHg or a ≥20% reduction from baseline.
Measured: Perioperative period
Incidence of hypoxemia
Defined as SpO₂ <90% lasting for over 10 s.
Measured: perioperative period
Number of intraoperative interventions
Number of intraoperative interventions (oxygen adjustment, hemodynamic drugs, airway management, conversion to general anesthesia)
Measured: perioperative period
Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
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).
Measured: Perioperative period
Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
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).
Measured: perioperative period
Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain).
Intraoperative pain intensity: Measured postoperatively based on patient recall using a 10-point Visual Analogue Scale (VAS, 0 = no pain, 10 = worst imaginable pain).
Measured: perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start15 Oct 2025
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149545
- Sponsor's protocol ID
- KS2025277
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2025
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiologist-led Deep Sedation Protocols for Pulsed Field Ablation for Atrial Fibrillation Using a Bipolar Tip-Catheter: The DEEP-PFA Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07149545
- Acronym / sponsor ID
- KS2025277
- Conditions
- Atrial Fibrillation (AF), PFA, Deep Sedation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 2 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A (Fentanyl + Midazolam) | Experimental | Drug: Arm A (Fentanyl + Midazolam)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. |
| Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) | Experimental | Drug: Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)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. |
| Arm C (Fentanyl + Dexmedetomidine) | Experimental | Drug: Arm C (Fentanyl + Dexmedetomidine)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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arm A (Fentanyl + Midazolam)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. | Drug | Arm A (Fentanyl + Midazolam) |
| Arm B (Flurbiprofen axetil + Fentanyl + Midazolam)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. | Drug | Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) |
| Arm C (Fentanyl + Dexmedetomidine)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. | Drug | Arm C (Fentanyl + Dexmedetomidine) |
Primary outcome
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.
6 secondary outcomes
Incidence of hypotension
Time frame: Perioperative period
Incidence of hypoxemia
Time frame: perioperative period
Number of intraoperative interventions
Time frame: perioperative period
Sedation difficulty score. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
Time frame: Perioperative period
Operator satisfaction. Score on a 5-point Likert scale (1=Very dissatisfied, 5=Very satisfied).
Time frame: perioperative period
Patient recall of intraoperative pain. Score on a 10-point Visual Analog Scale (0=No pain, 10=Worst pain).
Time frame: perioperative period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm A (Fentanyl + Midazolam), Arm B (Flurbiprofen axetil + Fentanyl + Midazolam) and Arm C (Fentanyl + Dexmedetomidine) in people with Atrial Fibrillation (AF) and PFA, run by Beijing Anzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with successful sedation at the start of ablation (time frame: At the initiation of ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.