CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation

A Randomized Control Trial to Compare the Efficacy and Safety of CARTO-Finder-guided Ablation Plus Pulmonary Vein Isolation and Multiscale Entropy-guided Ablation Plus Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation

This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.

Study Overview

• Status: Not yet recruiting
• Conditions: Persistent Atrial Fibrillation
• Intervention / Treatment: Procedure: CARTO-Finder-guided ablation plus PVI; Procedure: Multiscale entropy-guided ablation plus PVI

Detailed Description

This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xu Liu, M.D.; Phone Number: 18017321689; Email: heartlx@sina.com

Study Locations

• China
  • Shanghai, China
    • Shanghai Chest Hospital
    • Contact: Xu Liu, Dr.; Phone Number: 18017321689
    • Principal Investigator: Xu Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18 to 80 years old
2. Persistent AF
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. Having moderate-to-severe pulmonary hypertension;
4. With myocardial infarction or stroke within 6 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was <40% measured by echocardiography;
7. Allergic to contrast media;
8. Contraindication to anticoagulation medications;
9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
10. Left atrial thrombus;
11. Having any contraindication to right or left sided heart catheterization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CARTO-Finder-guided ablation plus PVI; Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.	Procedure: CARTO-Finder-guided ablation plus PVI; CARTO-Finder-guided ablation plus PVI
Experimental: Multiscale entropy-guided ablation plus PVI; Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.	Procedure: Multiscale entropy-guided ablation plus PVI; The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate	AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration	up to 24 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative AF recurrence rate	AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration	up to 24 months after enrollment
Postoperative AFL/AT rate	Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration	up to 24 months after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the diameter of the left atrium	Changes in the diameter of the left atrium	up to 24 months after enrollment
Changes in the diameter of the left ventricular ejection fraction	Changes in the diameter of the left ventricular ejection fraction	up to 24 months after enrollment
Incidence of complications	death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding	up to 24 months after enrollment

Collaborators and Investigators

• Sponsor: Shanghai Chest Hospital
• Collaborators: Shandong University of Traditional Chinese Medicine; Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine; Department of Cardiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology; Department of Cardiology, Affiliated Hospital of Jining Medical University; Department of Cardiology, Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine; Department of Cardiology, Yuhuan Second People's Hospital; Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine; Department of Cardiology, The PLA Navy Anqing Hospital; Department of Cardiology, Jinan City People's Hospital; Department of Cardiology, Xuzhou Central Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: July 5, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 11, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: catheter ablation; persistent atrial fibrillation; CARTO-Finder-guided ablation; Multiscale entropy-guided ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: Find-AF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes