Back to resultsCARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation
Primary Purpose
Persistent Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Multiscale entropy-guided ablation plus PVI
CARTO-Finder-guided ablation plus PVI
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Atrial Fibrillation focused on measuring persistent atrial fibrillation, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided ablation
Eligibility Criteria
Inclusion Criteria:
- Aged 18 to 80 years old
- Persistent AF
- Nonresponse or intolerance to ≥1 antiarrhythmic drug
Exclusion Criteria:
- With uncontrolled congestive heart failure;
- Having significant valvular disease;
- Having moderate-to-severe pulmonary hypertension;
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial thrombus;
- Having any contraindication to right or left sided heart catheterization
Sites / Locations
- Shanghai Chest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
CARTO-Finder-guided ablation plus PVI
Multiscale entropy-guided ablation plus PVI
Arm Description
Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.
Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Postoperative AF recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Postoperative AFL/AT rate
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Full Information
NCT ID
NCT05454111
First Posted
July 5, 2022
Last Updated
July 11, 2022
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
1. Study Identification
Unique Protocol Identification Number
NCT05454111
Brief Title
CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the 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
4. Oversight
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
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Atrial Fibrillation
Keywords
persistent atrial fibrillation, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CARTO-Finder-guided ablation plus PVI
Arm Type
Active Comparator
Arm Description
Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.
Arm Title
Multiscale entropy-guided ablation plus PVI
Arm Type
Experimental
Arm Description
Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.
Intervention Type
Procedure
Intervention Name(s)
Multiscale entropy-guided ablation plus PVI
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
CARTO-Finder-guided ablation plus PVI
Intervention Description
CARTO-Finder-guided ablation plus PVI
Primary Outcome Measure Information:
Title
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Description
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Time Frame
up to 24 months after enrollment
Secondary Outcome Measure Information:
Title
Postoperative AF recurrence rate
Description
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Time Frame
up to 24 months after enrollment
Title
Postoperative AFL/AT rate
Description
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Time Frame
up to 24 months after enrollment
Other Pre-specified Outcome Measures:
Title
Changes in the diameter of the left atrium
Description
Changes in the diameter of the left atrium
Time Frame
up to 24 months after enrollment
Title
Changes in the diameter of the left ventricular ejection fraction
Description
Changes in the diameter of the left ventricular ejection fraction
Time Frame
up to 24 months after enrollment
Title
Incidence of complications
Description
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
Time Frame
up to 24 months after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18 to 80 years old
Persistent AF
Nonresponse or intolerance to ≥1 antiarrhythmic drug
Exclusion Criteria:
With uncontrolled congestive heart failure;
Having significant valvular disease;
Having moderate-to-severe pulmonary hypertension;
With myocardial infarction or stroke within 6 months of screening;
With Significant congenital heart disease;
Ejection fraction was <40% measured by echocardiography;
Allergic to contrast media;
Contraindication to anticoagulation medications;
Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
Left atrial thrombus;
Having any contraindication to right or left sided heart catheterization
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xu Liu, M.D.
Phone
18017321689
Email
heartlx@sina.com
Facility Information:
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Liu, Dr.
Phone
18017321689
First Name & Middle Initial & Last Name & Degree
Xu Liu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation
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