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

NCT ID: NCT05454111

Last Updated: 2022-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Persistent Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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CARTO-Finder-guided ablation plus PVI

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

Group Type ACTIVE_COMPARATOR

CARTO-Finder-guided ablation plus PVI

Intervention Type PROCEDURE

CARTO-Finder-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.

Group Type EXPERIMENTAL

Multiscale entropy-guided ablation plus PVI

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

CARTO-Finder-guided ablation plus PVI

CARTO-Finder-guided ablation plus PVI

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine

UNKNOWN

Sponsor Role collaborator

Wuhan Central Hospital

OTHER

Sponsor Role collaborator

Department of Cardiology, Affiliated Hospital of Jining Medical University

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, Yuhuan Second People's Hospital

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, The PLA Navy Anqing Hospital

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, Jinan City People's Hospital

UNKNOWN

Sponsor Role collaborator

Department of Cardiology, Xuzhou Central Hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xu Liu

Professor, deputy director of cardiology department of Shanghai Chest Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shanghai Chest Hospital

Shanghai, , China

Site Status

Countries

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China

Central Contacts

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Xu Liu, M.D.

Role: CONTACT

18017321689

Facility Contacts

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Xu Liu, Dr.

Role: primary

18017321689

Other Identifiers

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Find-AF

Identifier Type: -

Identifier Source: org_study_id

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