Pulsed Field Ablation in Three Different Substrate Ablation Strategies for Persistent Atrial Fibrillation
NCT ID: NCT06739512
Last Updated: 2024-12-18
Study Results
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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NOT_YET_RECRUITING
NA
600 participants
INTERVENTIONAL
2024-12-25
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Anatomical Guided Ablation Group
This group will undergo pulmonary vein isolation (PVI) combined with anatomical linear ablation based on predefined anatomical landmarks (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification), including lines such as the mitral isthmus and roofline. The ablation will aim to create bidirectional block without relying on electrogram-based mapping.
Anatomical Guided Ablation
Ablation using PFA. Guided by anatomical landmarks without potential mapping
Electrogram Guided Ablation Group
This group will undergo PVI and targeted ablation of atrial fibrillation "drivers" identified through electrogram-guided mapping. The mapping will focus on electrograms with characteristics such as spatial-temporal dispersion, high-frequency potentials, and short local cycle lengths.
Electrogram Guided Ablation
Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.
Extensive Electro-Anatomical Guided Ablation Group
This group will receive PVI and a combination of anatomical linear ablation (a complete posterior wall box isolation to ensure comprehensive atrial substrate modification) and electrogram-guided ablation. It represents an extensive strategy that integrates both anatomical and potential-based mapping for optimized ablation targeting.
Extensive Electro-Anatomical Guided Ablation
Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
Interventions
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Extensive Electro-Anatomical Guided Ablation
Ablation using PFA. Combination of anatomical and electrogram-guided ablation techniques.
Anatomical Guided Ablation
Ablation using PFA. Guided by anatomical landmarks without potential mapping
Electrogram Guided Ablation
Ablation using PFA. Guided by real-time electrogram characteristics from a multi-electrode catheter.
Eligibility Criteria
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Inclusion Criteria
2. Ineffectiveness or intolerance to at least one Class I or III anti-arrhythmic drug.
Exclusion Criteria
2. Presence of a left atrial thrombus on recent imaging.
3. Recent myocardial infarction or severe heart failure (LVEF ≤ 30%).
4. Current Severe Infection.
18 Years
80 Years
ALL
No
Sponsors
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Albert Einstein College of Medicine and Montefiore Medical Center
UNKNOWN
Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
UNKNOWN
Shandong University of Traditional Chinese Medicine
OTHER
Yuhuan Second People's Hospital
UNKNOWN
Changshu Hospital of Traditional Chinese Medicine
OTHER
Jinan People's Hospital
UNKNOWN
Xuzhou Central Hospital
OTHER
The PLA Navy Anqing Hospital
UNKNOWN
Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
MD
Locations
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No. 241, West Huaihai Road
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Xu Liu, MD
Role: primary
Other Identifiers
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EXT-II
Identifier Type: -
Identifier Source: org_study_id