Deep Sedation in Catheter Ablation of Atrial Fibrillation

NCT06836999 | Not Yet Recruiting

• 2 other identifiers: TEMP-000758ChiCTR2500096790
• Study Type: interventional
• Target: 1,334
• Locations: 1 country
• Sites: 16

Brief 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 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

Keywords

deep sedation; conscious sedation; catheter ablation; atrial fibrillation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Score of patients' intraprocedural experiences

  during the CA procedure

• Score of ablators', staffs',nurse's intraprocedural experiences

  during the CA procedure

• respiratory system safety outcome

  From the start of sedation to the end of the procedure

• Rate of re-ablation acceptances

  4-12month post-ablation

• Procedure time

  during the CA procedure

Study Arms (2)

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

Procedure: deep sedation

CS group

SHAM COMPARATOR

The CA procedure will be performed under conscious sedation in the control group mainly with fentanyl.

Procedure: Conscious sedation

Interventions

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.

DS group

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.

CS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ● Patients diagnosed with AF (paroxysmal, persistent, or long-standing) at 18-75 years old who are eligible for the CA procedure

You may not qualify if:

• 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
• 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.).

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (16)

Anhui Provincial Hospital

Hefei, Anhui, 230036, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

NanFang Hospital

Guangzhou, Guangdong, 510515, China

Location

Jiangsu Provincial Hospital

Nanjing, Jiangsu, 210029, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

Location

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330008, China

Location

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Qingdao Municipal Hospital

Qingdao, Shandong, 266011, China

Location

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

Shanxi Cardiovascular Hospital

Taiyuan, Shanxi, 030001, China

Location

Tianjin Chest Hospital

Tianjin, Tianjin Municipality, 300010, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300050, China

Location

The Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Sir Rung Rung Shaw Hospital, Zhejiang University School Of Medicine

Hangzhou, Zhejiang, 310016, China

Location

The Affiliated Hospital Of Medical School Of Ningbo University

Ningbo, Zhejiang, 315211, China

Location

Related Publications (2)

• 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.

  PMID: 37470452 BACKGROUND

• Benzoni T, Agarwal A, Cascella M. Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK551685/

  PMID: 31869149 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Deep Sedation; Conscious Sedation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia

Study Officials

• Yunlong Xia, Ph.D

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunlong Xia, Ph.D

CONTACT

+86 18098875555; yunlong_xia@126.com

Chengming Ma, MD

CONTACT

+86 18098875759; machengming@dmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 20, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (16)