Comparison of Different Pulsed Field Ablation Catheters in Atrial Fibrillation
NCT ID: NCT07036965
Last Updated: 2025-06-25
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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RECRUITING
NA
292 participants
INTERVENTIONAL
2025-06-30
2031-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CardiPulse Group
Patients accept atrial fibrillation ablation with CardiPulse pulsed field ablation catheter
CardiPulse
abc
FaraPulse Group
Patients accept atrial fibrillation ablation with FaraPulse pulsed field ablation catheter
FaraPulse
bcd
Interventions
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CardiPulse
abc
FaraPulse
bcd
Eligibility Criteria
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Inclusion Criteria
2. Diagnosed with drug-refractory, symptomatic atrial fibrillation.
3. The patient has a high risk of stroke (CHA2DS2-VA score ≥ 2).
4. Have a situation of:
1. requires oral anticoagulation therapy
2. high bleeding risk (HAS-BLED score ≥ 3) that unsuitable for or unwilling to undergo long-term oral anticoagulation therapy.
5. Subjects are able to understand the purpose of the study, voluntarily participate in the study and sign the informed consent, and are willing to complete the follow-up according to the requirements of the program.
Exclusion Criteria
2. Atrial fibrillation was secondary to thyroid disease or other reversible reasons.
3. Left atrial anteroposterior diameter \>50 mm.
4. Evidence of left atrial or left atrial appendage thrombus on imaging examination.
5. Concurrent other arrhythmias required for catheter ablation (e.g., atrioventricular reentrant tachycardia, atrioventricular nodal reentrant tachycardia, pre-excitation syndrome) prior to enrollment.
6. Rheumatic heart disease.
7. Left ventricular ejection fraction \<40% or New York Heart Association (NYHA) class III/IV.
8. Unstable angina.
9. Myocardial infarction (MI), coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI) within 3 months prior to enrollment.
10. History of prior left atrial appendage closure, patent foramen ovale closure, atrial septal defect closure, or repair surgery.
11. Implantation of a mechanical mitral valve prosthesis or metallic annuloplasty rings.
12. Presence of intracardiac thrombus, space-occupying lesions, or other abnormalities that preclude vascular access or catheter manipulation.
13. Contraindications to anticoagulation or history of coagulation disorders/abnormal bleeding.
14. Active systemic infection.
15. Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m² or history of renal dialysis.
16. Pregnancy or breastfeeding.
17. Life expectancy \<12 months (e.g., advanced malignancy).
18. Current or anticipated participation in other drug or device clinical trials.
19. Any other condition or abnormality deemed by the investigator to warrant exclusion.
118 Years
ALL
No
Sponsors
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Hangzhou Dinova EP Technology Co., Ltd
INDUSTRY
Responsible Party
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Locations
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Ningbo First Hospital
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CP-IIS-007
Identifier Type: -
Identifier Source: org_study_id
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