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

Not Applicable

Not yet recruiting

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: CARTO-Finder-guided ablation plus PVI; Procedure: Multiscale entropy-guided ablation plus PVI

• Registration Number: NCT05454111
• Lead Sponsor: Shanghai Chest Hospital

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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-05
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-12
• Last Update Posted: 2022-07-12
• Study Start: 2022-09-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CARTO-Finder-guided ablation plus PVI	CARTO-Finder-guided ablation plus PVI	Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors.
Multiscale entropy-guided ablation plus PVI	Multiscale entropy-guided ablation plus PVI	Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Chest Hospital; 🇨🇳 Shanghai, China