Atrial FibrillationPRIORI-AFNCT06836999
Deep Sedation in Catheter Ablation of Atrial Fibrillation
A study testing deep sedation and Conscious sedation in people with Atrial Fibrillation and Atrial Fibrillation, Paroxysmal or Persistent, run by The First Affiliated Hospital of Dalian Medical University at 16 sites in China.
Trial summary
The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Fibrillation, Paroxysmal or Persistent, Deep Sedations
- What is being tested?
- deep sedation and Conscious sedation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,334 participants
- Where
- 16 sitesChina
- Study dates
- 3 Mar 2025to 31 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
Who cannot join
- has received CA procedure for AF or atrial septal defect repair before enrollment
- left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
- eGFR<30mL/min/1.73㎡
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack [TIA])
- acute or severe systemic infection
- intolerant to sedation or with a history suggestive of sleep apnea
Show all 14Show fewer
- BMI > 35 kg/㎡
- has contraindications to procedural sedation or refused to participate in this trial
- Congenital heart disease, thyroid dysfunction, severe hepatic insufficiency (Child-Pugh classification B-C), severe coagulation dysfunction (international normalized ratio (INR) > 1.5 or partial activated prothrombin time (APTT) prolonged by ≥ 10 seconds, or plasma prothrombin time (PT) prolonged by ≥ 3 seconds, or fibrinogen (Fib) ≤ 1.5 g/L), or active bleeding
- pregnant women, breastfeeding women or women who plan to become pregnant during the study period, those who have a positive pregnancy test result during the screening period
- life expectancy < 12 months
- those who have participated in other clinical drug trials within 3 months prior to enrollment
- those who are known to be allergic to any of the ingredients such as lidocaine, propofol, soybeans, peanuts, etc.
- those who, in the judgment of the investigator, are not suitable for this clinical study (e.g., not in line with the treatment that the research participants the treatment, research participant compliance, etc.).
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
China16 sites
First Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116011
Xiaomeng Yin, Ph.D, +86 18098875778, dr.yinxm@163.com
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Yumei Xue, +86 13570082363, 13570082363@139.com
Yumei Xue
NanFang Hospital
Guangzhou, Guangdong, 510515
Yuegang Wang, +86 13725265686, 13725265686@139.com
Yuegang Wang
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310009
Yaping Wang, +86 13805725837, wangypzju@163.com
Yaping Wang
Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine
Hangzhou, Zhejiang, 310016
Sheng Xia, +86 13857158757, 13857158757@139.com
Xia Sheng
Anhui Provincial Hospital
Hefei, Anhui, 230036
Hao Su, +86 13205517890, 13330087693@wo.cn
Su Hao
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Ran Yin, +86 18679133150, 18679133150@wo.cn
Ran Yin
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330008
Qi Chen, +86 13330087693, 13330087693@wo.cn
Qi Chen
Jiangsu Provincial Hospital
Nanjing, Jiangsu, 210029
Minglong Chen, +86 13809000791, 13809000791@139.com
Minglong Chen
The Affiliated Hospital Of Medical School Of Ningbo University
Ningbo, Zhejiang, 315211
Huimin Chu, +86 13566336742, markchu@126.com
Huimin Chu
Qingdao Municipal Hospital
Qingdao, Shandong, 266011
Bingong Li, +86 17669657168, 17669657168@wo.cn
Bingong Li
Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Zhigang Zhang, +86 18221885011, 18221885011@139.com
Zhigang Zhang
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006
Tingbo Jiang, +86 18906201122, 18906201122@189.com
Tingbo Jiang
Shanxi Cardiovascular Hospital
Taiyuan, Shanxi, 030001
Haixiong Wang, +86 15003433600, 15003433600@139.com
Haixiong Wang
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300010
Fengmin Lu, +86 13902114455, 13902114455@139.com
Fengmin Lu
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300050
Heng Cai, +86 13821378394, caihengch@163.com
Heng Cai
About this study
Official title: Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
The current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.
- Conditions
- Atrial Fibrillation, Atrial Fibrillation, Paroxysmal or Persistent, Deep Sedations, Conscious Sedation
- Being tested
- deep sedation, Conscious sedation
- Keywords
- deep sedation, conscious sedation, catheter ablation, atrial fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep sedationProcedure or surgery
The deep sedation was inducted using atropine 0.5 mg iv administered 15 min before the procedure to avoid aspiration. In the EP lab, anesthesia preparation is performed, including invasive arterial blood pressure monitoring via puncture of the radial artery or brachial artery. Noninvasive BP monitoring every 5 minutes is also permitted. Subsequently, midazolam 1-2mg or accompanied with propofol 0.3-0.5 mg/kg is administered intravenously at the start of the CA procedure (i.e., femoral vein puncture), and fentanyl 25 µg is administered intravenously. Then, continuous titrated infusion of propofol 0.2-0.5mg/kg/h for anesthesia maintenance throughout the CA procedure. An additional iv fentanyl (25-50 µg) is administrated at the beginning of RF applications. Further boluses or additional drugs are administrated as needed to maintain analgesia during the procedure. The anesthesiologist is responsible for administering anesthesia and administering medication.
Conscious sedationProcedure or surgery
This protocol is aimed at analgesia, with local infiltration of lidocaine for femoral vein puncture followed by intravenous administration of fentanyl (1-2 ug/kg/h). The operator determines the dose of fentanyl and midazolam. A midazolam 1-5 mg bolus is administrated before electrical cardioversion is performed or when the patient is nervous.
| Study group | Role | What they receive |
|---|---|---|
| DS group | Experimental | The CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic Receives: Procedure: deep sedation |
| CS group | Sham comparator | The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl. Receives: Procedure: Conscious sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhythm outcomes
The primary effectiveness endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month (9 months) after the procedure without taking I/III AADs. Patients who had to redo ablation or failed to discontinue I/III AADs after the blanking period are considered as primary endpoint
Measured: 4-12month post-ablation
Secondary outcomes (7)
Score of patients' intraprocedural experiences
Questionnaires for patient：QoR-40 and Likelihood to recommend (LTR).
Measured: during the CA procedure
Score of ablators', staffs',nurse's intraprocedural experiences
Likelihood to recommend (LTR) Questionnaire
Measured: during the CA procedure
respiratory system safety outcome
the incidence of intraprocedural severe decrease in blood oxygenation (decrease in fingertip oxygen saturation to less than 90% or a >10% decrease in fingertip oxygen saturation from baseline)，apnea, respiratory depression, need for ventilator-assisted ventilation, and need for respiratory stimulant therapy
Measured: From the start of sedation to the end of the procedure
Rate of re-ablation acceptances
Rate of re-ablation acceptances if AF/AT recurrences.
Measured: 4-12month post-ablation
Procedure time
Procedure time (skin to skin), fluoroscopy, ablation time, etc.
Measured: during the CA procedure
The dosage of painkillers
The dosage of painkillers
Measured: during the CA procedure
the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
Measured: From the start of sedation to the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start3 Mar 2025 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- 1,334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunlong Xia, Ph.D, Principal investigator, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06836999
- Sponsor's protocol ID
- TEMP-000758
- Other IDs
- ChiCTR2500096790
- Acronym
- PRIORI-AF
- Status last verified
- Dec 2024
- First submitted
- 16 Feb 2025
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To protect the privacy of subjects, the study data can be accessed by requesting from the PI.
Publications
Grimaldi M, Quadrini F, Caporusso N, Troisi F, Vitulano N, Delmonte V, Di Monaco A. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023 Aug 2;25(9):euad222. doi: 10.1093/europace/euad222.
PubMed 37470452Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/
PubMed 31869149
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Deep Sedation vs. Conscious Sedation in Catheter Ablation in Patients With Atrial Fibrillation: Intraprocedural Management and Outcome Evaluation
- ClinicalTrials.gov ID
- NCT06836999
- Acronym / sponsor ID
- PRIORI-AF / TEMP-000758
- Conditions
- Atrial Fibrillation, Atrial Fibrillation, Paroxysmal or Persistent, Deep Sedations, Conscious Sedation
- Keywords
- deep sedation, conscious sedation, catheter ablation, atrial fibrillation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,334 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Feb 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 current practice of anesthesia for atrial fibrillation catheter ablation （CA） procedure is inconsistent, including general anesthesia, deep sedation, and conscious sedation.Due to the nature of deep sedation, it has been continuously gaining its position as one of the crucial components in standard practices of atrial fibrillation ablation during the last decade. Currently, a considerable number of procedures have been done using conscious sedation. Previous studies explored the benefits obtained from the employment of deep sedation in AF ablation procedures, mainly focused on pain reduction and intra-procedural safety. However, the benefits on long-term rhythmic outcomes, peri-procedural safety as well as benefits on procedural parameters and peri-procedural experiences from patients/ablators/lab staff have yet not to be thoroughly studied. We plan to conduct a prospective, multicenter, randomized, controlled trial to evaluate the benefits of deep sedation in catheter ablation of paroxysmal and persistent AF in multiple prospective, i.e., quantified intraprocedural patients / physicians / lab staffs / mapper clinical specialist experiences, and the procedure safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DS group | Experimental | Procedure: deep sedationThe CA procedure will be performed under deep sedation in the study group mainly with propofol for sedation and fentanyl for analgesic |
| CS group | Sham comparator | Procedure: Conscious sedationThe CA procedure will be performed under conscious sedation in the control group mainly with fentanyl. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
Key exclusion criteria (14 listed)
- has received CA procedure for AF or atrial septal defect repair before enrollment
- left atrial diameter (LAD) ≥55 mm or thrombosis in the left atrium;
- eGFR<30mL/min/1.73㎡
- a history of cerebrovascular disease within the last three months (including stroke and transient ischemic attack [TIA])
- acute or severe systemic infection
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 |
|---|---|---|
| deep sedationThe deep sedation was inducted using atropine 0.5 mg iv administered 15 min before the procedure to avoid aspiration. In the EP lab, anesthesia preparation is performed, including invasive arterial blood pressure monitoring via puncture of the radial artery or brachial artery. Noninvasive BP monitoring every 5 minutes is also permitted. Subsequently, midazolam 1-2mg or accompanied with propofol 0.3-0.5 mg/kg is administered intravenously at the start of the CA procedure (i.e., femoral vein puncture), and fentanyl 25 µg is administered intravenously. Then, continuous titrated infusion of propofol 0.2-0.5mg/kg/h for anesthesia maintenance throughout the CA procedure. An additional iv fentanyl (25-50 µg) is administrated at the beginning of RF applications. Further boluses or additional drugs are administrated as needed to maintain analgesia during the procedure. The anesthesiologist is responsible for administering anesthesia and administering medication. | Procedure or surgery | DS group |
| Conscious sedationThis protocol is aimed at analgesia, with local infiltration of lidocaine for femoral vein puncture followed by intravenous administration of fentanyl (1-2 ug/kg/h). The operator determines the dose of fentanyl and midazolam. A midazolam 1-5 mg bolus is administrated before electrical cardioversion is performed or when the patient is nervous. | Procedure or surgery | CS group |
Primary outcome
Rhythm outcomes
Time frame: 4-12month post-ablation
The primary effectiveness endpoint is the freedom from documented atrial arrhythmia (AF/AFL/AT lasting for over 30 seconds) recurrence monitored by ECG, 7-day ambulatory ECG, or equivalent cardiac monitoring from 4th to 12th month (9 months) after the procedure without taking I/III AADs. Patients who had to redo ablation or failed to discontinue I/III AADs after the blanking period are considered as primary endpoint
7 secondary outcomes
Score of patients' intraprocedural experiences
Time frame: during the CA procedure
Score of ablators', staffs',nurse's intraprocedural experiences
Time frame: during the CA procedure
respiratory system safety outcome
Time frame: From the start of sedation to the end of the procedure
Rate of re-ablation acceptances
Time frame: 4-12month post-ablation
Procedure time
Time frame: during the CA procedure
The dosage of painkillers
Time frame: during the CA procedure
the incidence of regurgitation and aspiration and oral mucosal damage caused by oropharyngeal airway
Time frame: From the start of sedation to the end of the procedure
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 4 Mar 2025.
- Background: PubMed 37470452Grimaldi M, Quadrini F, Caporusso N, Troisi F, Vitulano N, Delmonte V, Di Monaco A. Deep sedation protocol during atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter. Europace. 2023 Aug 2;25(9):euad222. doi: 10.1093/europace/euad222.
- Background: PubMed 31869149Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/
- Individual participant dataSharing planned: No. To protect the privacy of subjects, the study data can be accessed by requesting from the PI.
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Atrial Fibrillation (AF)
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.
Yunlong Xia, Ph.D principal investigator
The First Affiliated Hospital of Dalian Medical University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep sedation and Conscious sedation in people with Atrial Fibrillation and Atrial Fibrillation, Paroxysmal or Persistent, run by The First Affiliated Hospital of Dalian Medical University at 16 sites 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 1 inclusion and 14 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: opening soon, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. Some participants in this study may receive a placebo. 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?
Contact Yunlong Xia, Ph.D (+86 18098875555, yunlong_xia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhythm outcomes (time frame: 4-12month post-ablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06836999, which also lists 2 linked publications.
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 4 Mar 2025.