Efficacy and Safety of Pulsed Field Ablation in Refractory Mitral Isthmus-dependent Atrial Flutter: Pulsed Field Ablation Vs. Radiofrequency Ablation: a Preliminary Randomized Controlled Study
NCT ID: NCT06850064
Last Updated: 2025-02-27
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
60 participants
INTERVENTIONAL
2025-02-24
2025-12-01
Brief Summary
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Detailed Description
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Study Design:
Randomized Groups: Patients will be randomly assigned to two groups:
Pulse Field Ablation (PFA) Group Radiofrequency Ablation (RFCA) Group
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiofrequency ablation unit
The patient underwent radiofrequency ablation treatment. After electrophysiological examination, radiofrequency ablation was performed.
Radiofrequency ablation
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
The pulse field ablation group
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
Pulse Field Ablation (PFA)
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
Interventions
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Pulse Field Ablation (PFA)
The pulse field ablation group will undergo pulse field ablation of the mitral valve commissure.
Radiofrequency ablation
In the radiofrequency ablation group, patients will undergo radiofrequency ablation targeted at the mitral valve commissure.
Eligibility Criteria
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Inclusion Criteria
1. Failure of drug therapy: At least one Class I or III antiarrhythmic drug (e.g., propafenone, amiodarone) fails to effectively control or prevent episodes.
2. Failure of catheter ablation: At least one previous attempt at radiofrequency catheter ablation (RFCA) targeting the mitral valve commissure has been unsuccessful (either due to recurrence post-procedure or failure to achieve bidirectional block at the commissure).
3.Intolerant to at least one antiarrhythmic drug (AAD). 4.The patient must be capable of and willing to provide written informed consent to participate in this study.
Exclusion Criteria
2. Presence of left atrial thrombus on preoperative imaging.
3. Life expectancy less than 1 year.
4. Coagulation disorders or contraindications to anticoagulant therapy.
18 Years
ALL
No
Sponsors
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Shanghai Chest Hospital
OTHER
Responsible Party
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Xu Liu
Professor
Locations
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Shanghai Chest Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MIDAF-PFA vs RF
Identifier Type: -
Identifier Source: org_study_id
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