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

Persistent Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05454111
• Other study ID #: Find-AF
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: July 2022
• Source: Shanghai Chest Hospital
• Contact: Xu Liu, M.D.
• Phone: 18017321689
• Email: heartlx[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Persistent Atrial Fibrillation

Intervention

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.
• CARTO-Finder-guided ablation plus PVI
CARTO-Finder-guided ablation plus PVI

Locations

Country	Name	City	State
China	Shanghai Chest Hospital	Shanghai

Sponsors (11)

Lead Sponsor

Collaborator

Shanghai Chest Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in the diameter of the left atrium	Changes in the diameter of the left atrium	up to 24 months after enrollment
Other	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
Other	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
Primary	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	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
Secondary	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