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

Shanghai Jiao Tong University

Status: Not yet enrolling

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Multiscale entropy-guided ablation plus PVI; Procedure: CARTO-Finder-guided ablation plus PVI

Study type: Interventional

Funder types: Other

Identifiers

NCT05454111

Find-AF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

CARTO-Finder-guided ablation plus PVI

Active Comparator group

Description:

Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.

Treatment:

Procedure: CARTO-Finder-guided ablation plus PVI

Multiscale entropy-guided ablation plus PVI

Experimental group

Description:

Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.

Treatment:

Procedure: Multiscale entropy-guided ablation plus PVI