Clinical trial NCT05454111: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Persistent Atrial Fibrillation
Keywords: persistent atrial fibrillation
catheter ablation
CARTO-Finder-guided ablation
Multiscale entropy-guided ablation
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
Collaborators: name: Shandong University of Traditional Chinese Medicine
name: Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
name: Department of Cardiology, The Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology
name: Department of Cardiology, Affiliated Hospital of Jining Medical University
name: Department of Cardiology, Yuhuan Second People's Hospital
name: Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine
name: Department of Cardiology, The PLA Navy Anqing Hospital
name: Department of Cardiology, Jinan City People's Hospital
name: Department of Cardiology, Xuzhou Central Hospital
First posted: 2022-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
timeFrame: up to 24 months after enrollment
Secondary outcomes:
measure: Postoperative AF recurrence rate
timeFrame: up to 24 months after enrollment
measure: Postoperative AFL/AT rate
timeFrame: up to 24 months after enrollment
Other outcomes:
measure: Changes in the diameter of the left atrium
timeFrame: up to 24 months after enrollment
measure: Changes in the diameter of the left ventricular ejection fraction
timeFrame: up to 24 months after enrollment
measure: Incidence of complications
timeFrame: up to 24 months after enrollment
Locations:
city: Shanghai
country: China
facility: Shanghai Chest Hospital
Study officials:
References: