Atrial Fibrillation (Paroxysmal)SEDATE-PFANCT07541339
Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation
A study testing conscious sedation in people with Atrial Fibrillation (Paroxysmal), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation (Paroxysmal)
- What is being tested?
- conscious sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 18 to 80 years
- Diagnosed with paroxysmal atrial fibrillation
- No prior history of catheter ablation for atrial fibrillation/atrial flutter
- Scheduled to undergo pulsed-field ablation
- Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments
Who cannot join
- Obstructive sleep apnea-hypopnea syndrome (OSAHS)
- Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
- Body mass index (BMI) >30 kg/m² or <20 kg/m²
- Preoperative pulse oxygen saturation (SpO₂) <93%
- Anticipated difficult airway
- Intolerance to general anesthesia (American Society of Anesthesiologists [ASA] physical status ≥Ⅳ)
Show all 19Show fewer
- Current left ventricular ejection fraction (LVEF) ≤40% or New York Heart Association (NYHA) functional class Ⅲ-Ⅳ
- Acute coronary syndrome within 3 months
- Within 3 months after percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG) or other cardiac/vascular surgeries
- Moderate/severe stenosis or severe regurgitation of aortic or mitral valve
- Acute cerebrovascular disease within 1 month
- Severe hepatic insufficiency (Child-Pugh Class C)
- Estimated glomerular filtration rate (eGFR) <45 mL/min/1.73m² or on dialysis
- History of chronic heavy alcohol consumption
- History of substance abuse
- Hypersensitivity to any medications used in the study protocol
- Pregnancy or lactation
- Concurrent participation in other interventional clinical trials
- Other conditions deemed unsuitable for study participation by the investigators
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial
The goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:
- Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia?
- What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.
Read more
Participants will:
- Receive the assigned anesthetic strategy combined with standardized PFA procedure
- Complete intraoperative vital sign and related index monitoring
- Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording
Read the detailed description
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, which severely impairs patients' quality of life and is closely associated with an elevated risk of complications including thromboembolism and heart failure. Rhythm control, particularly catheter ablation, has become a cornerstone of AF management. In recent years, pulsed-field ablation (PFA) has emerged as a novel catheter ablation technique for AF. It demonstrates non-inferior ablation efficacy to conventional radiofrequency ablation, with the advantages of minimal injury to peri-myocardial tissues, high procedural efficiency and a low incidence of complications, thus serving as a promising alternative for AF catheter ablation.
Unlike radiofrequency ablation, PFA delivers high-voltage electric fields during the procedure, for which local anesthesia fails to achieve satisfactory sedation and analgesia. General anesthesia (GA) is currently the main anesthetic approach for PFA to ensure adequate intraoperative immobilization and provide stable conditions for precise procedural manipulation. However, GA has notable limitations: first, the central inhibitory effects of general anesthetics and procedural stress-induced responses are prone to cause perioperative hemodynamic instability, leading to adverse events such as hypotension and hypoxemia, which not only increase procedural risks but also exert adverse impacts on short- and long-term patient prognosis; second, GA usually requires endotracheal intubation or laryngeal mask ventilation, which may cause retropharyngeal injury and raise the risk of complications like bleeding or hematoma; third, GA incurs relatively high medical costs, further increasing the economic burden on patients.
In light of these unmet clinical needs, several observational studies have demonstrated the feasibility of deep or conscious sedation during PFA procedures. Nevertheless, sedation strategies vary across centers, and most findings are based on single-center, small-sample empirical summaries, lacking high-quality evidence from large-sample, rigorously designed randomized controlled trials (RCTs). Our team has previously explored a conscious sedation strategy in over 200 patients, and the results showed that this strategy could achieve satisfactory sedation and analgesia for PFA, significantly reduce the risk of GA-related hemodynamic instability, and yield favorable postoperative feedback from patients.
Given the sufficient evidence supporting the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (PAF), this study intends to conduct a single-center, 1:1 randomized, single-blind controlled trial to compare the safety and efficacy of conscious sedation and GA in PFA for PAF, aiming to provide an evidence-based basis for the selection of an optimal sedation regimen for PFA procedures.
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Being tested
- conscious sedation, General Anesthesia (control group)
- Keywords
- Paroxysmal atrial fibrillation, Pulsed-field ablation, Conscious sedation, General anesthesia, Efficacy, Safety
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conscious sedationProcedure or surgery
Medications: Remimazolam toluenesulfonate injection (25 mg) + Fentanyl citrate injection (0.1 mg) + Lidocaine (100 mg).
Administration method:
Remimazolam: 2 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 1 mg/mL. The target Bispectral Index (BIS) is 60-80, and the infusion rate of remimazolam is adjusted according to the BIS and patient responses.
Fentanyl citrate: 5 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 0.01 mg/mL. Dose reduction and slower injection rate are required for patients with hepatic/renal insufficiency, obesity, or elderly/weak conditions.
General Anesthesia (control group)Procedure or surgery
Also called general anesthesia
After femoral vein puncture, anesthesia induction was performed with remimazolam (0.2-0.3 mg/kg), sufentanil (0.3-0.4 μg/kg) and rocuronium (0.6 mg/kg) following standard monitoring and preoxygenation. A laryngeal mask airway was inserted upon loss of consciousness and adequate muscle relaxation, with lung-protective mechanical ventilation applied at tidal volume 6-8 mL/kg, respiratory rate 10-14 breaths/min, I:E 1:2, FiO₂ 60% and fresh gas flow 2-3 L/min to maintain PaCO₂ at 35-45 cmH₂O. Anesthesia was maintained with continuous intravenous ciprofol (0.4-1 mg/kg/h) and remifentanil (0.1-0.2 μg/kg/min) to keep BIS 60-80 and MAP >70 mmHg, with vasoactive agents as needed. Anesthetics were discontinued before surgery end; the laryngeal mask airway was removed after the patient regained consciousness with satisfactory spontaneous breathing, and antagonistic drugs were used if necessary.
| Study group | Role | What they receive |
|---|---|---|
| conscious sedation group | Experimental | A conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists. Receives: Procedure: conscious sedation |
| General anesthesia group | Active comparator | The general anesthesia group adopted a standardized general anesthesia process of remimazolam + sufentanil + rocuronium for anesthesia induction, and remimazolam + remifentanil for anesthesia maintenance. Receives: Procedure: General Anesthesia (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
persistent systolic blood pressure <85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ <85%) for more than 60 seconds.
Measured: During procedure
Secondary outcomes (16)
Individual components of the primary composite endpoint
persistent systolic blood pressure <85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ <85%) for more than 60 seconds.
Measured: During procedure
The number of occurrences of each component of the primary outcome
The number of occurrences of each component of the primary outcome: (1) Systolic blood pressure persistently below 85 mmHg for more than 60 sec; or (2) Persistent hypoxemia (SpO₂ < 85%) for more than 60 seconds.
Measured: During procedure
Sedation difficulty score
1-10; 1 = easiest, 10 = most difficult
Measured: During procedure
Total procedure time
from femoral vein puncture to sheath removal
Measured: During procedure
Left atrial dwell time
The duration that the catheter stays in the left atrium
Measured: During procedure
Total number of ablations
The total number of ablation discharges
Measured: During procedure
Total ablation duration
The total ablation discharge time
Measured: During procedure
Fluoroscopy time
Fluoroscopy time
Measured: During procedure
Radiation dose
Radiation dose
Measured: During procedure
Acute pulmonary vein isolation rate
Acute pulmonary vein isolation rate
Measured: During procedure
Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia
Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia
Measured: During procedure
Operative Sedation Assessment Scale
Please ask the patient to recall how much pain they felt during the surgery?（0-10, the higher the score, the more severe the pain）
Measured: 12-24 hours postoperatively
Atrial fibrillation recurrence at 30 days post-procedure
Atrial fibrillation recurrence at 30 days post-procedure
Measured: Day30
Atrial fibrillation recurrence at 90 days post-procedure
Atrial fibrillation recurrence at 90 days post-procedure
Measured: Day90
Atrial fibrillation burden at 90 days post-procedure
Use 3 days of electrocardiogram patch monitoring to assess the burden of atrial fibrillation（Atrial fibrillation burden (%) = Total duration of atrial fibrillation ÷ Effective monitoring duration × 100%）
Measured: Day90
Serious adverse events
SAE refers to adverse reactions that meet any of the following criteria:
- Death or life-threatening
- Resulting in severe and permanent disability
- Requiring hospitalization or prolonging hospital stay
- Causing congenital abnormalities or birth defects in offspring
- A significant medical event determined by the researcher to cause major harm or injury to the subject, which may require drug treatment or surgical intervention to prevent the occurrence of other conditions as defined by SAE (such as death, permanent disability, hospitalization, etc.).
Measured: Day0-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (Paroxysmal)Studies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NingZhou, Beijing Anzhen Hospital
- Investigators
- Ning Zhou, Study chair, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541339
- Sponsor's protocol ID
- (2026) Kelunshen No.1
- Acronym
- SEDATE-PFA
- Status last verified
- Apr 2026
- First submitted
- 19 Mar 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Conscious Sedation Versus General Anesthesia in Pulsed-Field Ablation for Paroxysmal Atrial Fibrillation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07541339
- Acronym / sponsor ID
- SEDATE-PFA / (2026) Kelunshen No.1
- Conditions
- Atrial Fibrillation (Paroxysmal)
- Keywords
- Paroxysmal atrial fibrillation, Pulsed-field ablation, Conscious sedation, General anesthesia, Efficacy, Safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 21 Apr 2026 (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 goal of this clinical trial is to compare the safety and efficacy of conscious sedation and general anesthesia in patients with paroxysmal atrial fibrillation undergoing their first pulsed-field ablation (PFA) procedure. It will also establish a scalable conscious sedation protocol for PFA. The main questions it aims to answer are:
- Does conscious sedation reduce the incidence of the composite safety endpoint (persistent hypotension or hypoxemia for more than 60 seconds intraoperatively) compared with general anesthesia?
- What are the differences in perioperative indicators and adverse events between the two anesthetic strategies in PFA for paroxysmal atrial fibrillation? Researchers will randomly assign eligible patients to a conscious sedation group or a general anesthesia group at a 1:1 ratio to compare the safety and efficacy of the two anesthetic approaches.
Participants will:
- Receive the assigned anesthetic strategy combined with standardized PFA procedure
- Complete intraoperative vital sign and related index monitoring
- Undergo follow-up visits at 12-24 hours, 30 days and 90 days after surgery for relevant index assessment and adverse event recording
Detailed description
Atrial fibrillation (AF) is the most prevalent cardiac arrhythmia, which severely impairs patients' quality of life and is closely associated with an elevated risk of complications including thromboembolism and heart failure. Rhythm control, particularly catheter ablation, has become a cornerstone of AF management. In recent years, pulsed-field ablation (PFA) has emerged as a novel catheter ablation technique for AF. It demonstrates non-inferior ablation efficacy to conventional radiofrequency ablation, with the advantages of minimal injury to peri-myocardial tissues, high procedural efficiency and a low incidence of complications, thus serving as a promising alternative for AF catheter ablation.
Unlike radiofrequency ablation, PFA delivers high-voltage electric fields during the procedure, for which local anesthesia fails to achieve satisfactory sedation and analgesia. General anesthesia (GA) is currently the main anesthetic approach for PFA to ensure adequate intraoperative immobilization and provide stable conditions for precise procedural manipulation. However, GA has notable limitations: first, the central inhibitory effects of general anesthetics and procedural stress-induced responses are prone to cause perioperative hemodynamic instability, leading to adverse events such as hypotension and hypoxemia, which not only increase procedural risks but also exert adverse impacts on short- and long-term patient prognosis; second, GA usually requires endotracheal intubation or laryngeal mask ventilation, which may cause retropharyngeal injury and raise the risk of complications like bleeding or hematoma; third, GA incurs relatively high medical costs, further increasing the economic burden on patients.
In light of these unmet clinical needs, several observational studies have demonstrated the feasibility of deep or conscious sedation during PFA procedures. Nevertheless, sedation strategies vary across centers, and most findings are based on single-center, small-sample empirical summaries, lacking high-quality evidence from large-sample, rigorously designed randomized controlled trials (RCTs). Our team has previously explored a conscious sedation strategy in over 200 patients, and the results showed that this strategy could achieve satisfactory sedation and analgesia for PFA, significantly reduce the risk of GA-related hemodynamic instability, and yield favorable postoperative feedback from patients.
Given the sufficient evidence supporting the efficacy and safety of PFA in the treatment of paroxysmal atrial fibrillation (PAF), this study intends to conduct a single-center, 1:1 randomized, single-blind controlled trial to compare the safety and efficacy of conscious sedation and GA in PFA for PAF, aiming to provide an evidence-based basis for the selection of an optimal sedation regimen for PFA procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conscious sedation group | Experimental | Procedure: conscious sedationA conscious sedation regimen based on remimazolam combined with fentanyl, plus lidocaine for antitussive therapy, administered by electrophysiologists. |
| General anesthesia group | Active comparator | Procedure: General Anesthesia (control group)The general anesthesia group adopted a standardized general anesthesia process of remimazolam + sufentanil + rocuronium for anesthesia induction, and remimazolam + remifentanil for anesthesia maintenance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 80 years
- Diagnosed with paroxysmal atrial fibrillation
- No prior history of catheter ablation for atrial fibrillation/atrial flutter
- Scheduled to undergo pulsed-field ablation
- Provide written informed consent for study participation and be able to complete all scheduled follow-up assessments
Key exclusion criteria (19 listed)
- Obstructive sleep apnea-hypopnea syndrome (OSAHS)
- Complicated with severe chronic obstructive pulmonary disease (COPD), asthma or other respiratory system diseases
- Body mass index (BMI) >30 kg/m² or <20 kg/m²
- Preoperative pulse oxygen saturation (SpO₂) <93%
- Anticipated difficult airway
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 |
|---|---|---|
| conscious sedationMedications: Remimazolam toluenesulfonate injection (25 mg) + Fentanyl citrate injection (0.1 mg) + Lidocaine (100 mg). Administration method: Remimazolam: 2 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 1 mg/mL. The target Bispectral Index (BIS) is 60-80, and the infusion rate of remimazolam is adjusted according to the BIS and patient responses. Fentanyl citrate: 5 vials mixed with 50 mL of 0.9% sodium chloride injection to prepare a solution with a concentration of 0.01 mg/mL. Dose reduction and slower injection rate are required for patients with hepatic/renal insufficiency, obesity, or elderly/weak conditions. | Procedure or surgery | conscious sedation group |
| General Anesthesia (control group)Also: general anesthesiaAfter femoral vein puncture, anesthesia induction was performed with remimazolam (0.2-0.3 mg/kg), sufentanil (0.3-0.4 μg/kg) and rocuronium (0.6 mg/kg) following standard monitoring and preoxygenation. A laryngeal mask airway was inserted upon loss of consciousness and adequate muscle relaxation, with lung-protective mechanical ventilation applied at tidal volume 6-8 mL/kg, respiratory rate 10-14 breaths/min, I:E 1:2, FiO₂ 60% and fresh gas flow 2-3 L/min to maintain PaCO₂ at 35-45 cmH₂O. Anesthesia was maintained with continuous intravenous ciprofol (0.4-1 mg/kg/h) and remifentanil (0.1-0.2 μg/kg/min) to keep BIS 60-80 and MAP >70 mmHg, with vasoactive agents as needed. Anesthetics were discontinued before surgery end; the laryngeal mask airway was removed after the patient regained consciousness with satisfactory spontaneous breathing, and antagonistic drugs were used if necessary. | Procedure or surgery | General anesthesia group |
Primary outcome
Primary outcome
Time frame: During procedure
persistent systolic blood pressure <85 mmHg for more than 60 seconds, or persistent hypoxemia (SpO₂ <85%) for more than 60 seconds.
16 secondary outcomes
Individual components of the primary composite endpoint
Time frame: During procedure
The number of occurrences of each component of the primary outcome
Time frame: During procedure
Sedation difficulty score
Time frame: During procedure
Total procedure time
Time frame: During procedure
Left atrial dwell time
Time frame: During procedure
Total number of ablations
Time frame: During procedure
Total ablation duration
Time frame: During procedure
Fluoroscopy time
Time frame: During procedure
Radiation dose
Time frame: During procedure
Acute pulmonary vein isolation rate
Time frame: During procedure
Arterial PaCO₂ immediately before discontinuation of sedation/anesthesia
Time frame: During procedure
Operative Sedation Assessment Scale
Time frame: 12-24 hours postoperatively
Atrial fibrillation recurrence at 30 days post-procedure
Time frame: Day30
Atrial fibrillation recurrence at 90 days post-procedure
Time frame: Day90
Atrial fibrillation burden at 90 days post-procedure
Time frame: Day90
Serious adverse events
Time frame: Day0-90
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 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.
Ning Zhou study chair
Beijing Anzhen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conscious sedation in people with Atrial Fibrillation (Paroxysmal), 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 5 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 28 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Primary outcome (time frame: During procedure). 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 28 Oct 2026.