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| ID | Type | Description | Link |
|---|---|---|---|
| ChiCTR2500096790 | Other Identifier | Chinese clinical trial registry |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| CS group | Sham Comparator | The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep sedation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 4-12month post-ablation |
| Measure | Description | Time Frame |
|---|---|---|
| Score of patients' intraprocedural experiences | Questionnaires for patient:QoR-40 and Likelihood to recommend (LTR). | during the CA procedure |
| Score of ablators', staffs',nurse's intraprocedural experiences |
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Inclusion Criteria:
● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunlong Xia, Ph.D | Contact | +86 18098875555 | yunlong_xia@126.com | |
| Chengming Ma, MD | Contact | +86 18098875759 | machengming@dmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yunlong Xia, Ph.D | The First Affiliated Hospital of Dalian Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Hefei | Anhui | 230036 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37470452 | Background | 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. | |
| 31869149 | Background | Benzoni 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/ |
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To protect the privacy of subjects, the study data can be accessed by requesting from the PI.
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The present trial utilized a centralized randomization system (IWRS) to facilitate the competitive enrollment of study participants and treatment randomization grouping. The investigator (anesthesiologist) carries out the given treatment according to the grouping information of the study participants. Throughout the course of the study, the treatment groups were kept blind to the researchers, with the exception of the anesthesiologist, the sponsor, and the study participants.
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| Conscious sedation | Procedure | 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. |
|
Likelihood to recommend (LTR) Questionnaire
| 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 | 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. | 4-12month post-ablation |
| Procedure time | Procedure time (skin to skin), fluoroscopy, ablation time, etc. | during the CA procedure |
| The dosage of painkillers | The dosage of painkillers | 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 | From the start of sedation to the end of the procedure |
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
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| NanFang Hospital | Guangzhou | Guangdong | 510515 | China |
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| Jiangsu Provincial Hospital | Nanjing | Jiangsu | 210029 | China |
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| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | 215006 | China |
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| The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330006 | China |
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| The Second Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | 330008 | China |
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| First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning | 116011 | China |
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| Qingdao Municipal Hospital | Qingdao | Shandong | 266011 | China |
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| Shanghai East Hospital | Shanghai | Shanghai Municipality | 200120 | China |
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| Shanxi Cardiovascular Hospital | Taiyuan | Shanxi | 030001 | China |
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| Tianjin Chest Hospital | Tianjin | Tianjin Municipality | 300010 | China |
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| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | 300050 | China |
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| The Second Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
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| Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine | Hangzhou | Zhejiang | 310016 | China |
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| The Affiliated Hospital Of Medical School Of Ningbo University | Ningbo | Zhejiang | 315211 | China |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D054810 | Deep Sedation |
| D016292 | Conscious Sedation |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
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