Status:
UNKNOWN
Ganglion Plexus Ablation in Persistent Atrial Fibrillation
Lead Sponsor:
Ning Zhou
Conditions:
Atrial Fibrillation, Persistent
Ganglionated Plexi
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study aims to investigate the long-term efficacy and safety of incorporating ganglionated plexus ablation into radiofrequency ablation strategies for persistent atrial fibrillation.
Detailed Description
1. Study Design: The study employs a parallel-group design with a 1:1 randomization ratio. Eligible patients meeting the specified criteria will be randomly assigned to either the conventional abl...
Eligibility Criteria
Inclusion
- Age between 18 and 80 years, regardless of gender.
- Patients confirmed by electrocardiogram or clinically diagnosed with persistent atrial fibrillation.
- Individuals scheduled to undergo atrial fibrillation catheter ablation.
- Willing to participate in the study and voluntarily sign the informed consent form.
Exclusion
- Patients with a history of prior atrial fibrillation ablation surgery.
- Left ventricular ejection fraction (LVEF) less than 35%.
- Left atrial anterior-posterior diameter greater than 50mm on echocardiography.
- Presence of contraindications for atrial fibrillation ablation, such as the presence of clear thrombus in the left atrium detected preoperatively.
- Patients with second-degree (Type II) or third-degree atrioventricular block.
- Individuals with significant congenital heart defects (such as atrial septal defects or severe pulmonary vein stenosis, excluding unclosed foramen ovale).
- Patients with implanted artificial valves.
- Diagnosed with hypertrophic cardiomyopathy, chronic obstructive pulmonary disease, or myxoma.
- Untreated or uncontrolled hyperthyroidism or hypothyroidism.
- Patients with active systemic infections.
- Individuals with a significant bleeding tendency or those undergoing active blood dialysis due to renal failure.
- Patients who have experienced myocardial infarction within the last 3 months or undergone any cardiac intervention/open-heart surgery.
- Presence of clear contraindications for interventional procedures, as determined by the investigator.
- Pregnant or lactating women, or those planning pregnancy during the study period.
- Participation in other drug or medical device clinical trials within the last 3 months.
- Patients deemed unsuitable for participation in this clinical trial by the investigator.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06181578
Start Date
January 1 2024
End Date
December 31 2024
Last Update
December 26 2023
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