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Active Not Recruiting
NCT03963349
THERMOCOOL SMARTTOUCH®SF Catheters With Ablation Index Study
Conditions: Paroxysmal Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 150
Sponsor: Biosense Webster, Inc.
Location: Shanghai General Hospital Shanghai Shanghai Municipality
Summary
A single-center, real word study of consecutive subjects who undergo radiofrequency ablation for paroxysmal AF using THERMOCOOL SMARTTOUCH®SF (STSF) Catheter guiding by Ablation Index (AI). Prospectively or retrospectively record 150 eligible subjects since 1st Jan 2019 to evaluate effectiveness and safety of STSF with AI.
Eligibility Criteria
Inclusion Criteria:
1. Age 18 years or older
2. Patient has PAF eligible for AI-guided catheter ablation with an STSF catheter per standard of care assessment
3. Able and willing to comply with all pre-, post- and follow-up testing and requirements
4. Able to sign EC-approved informed consent form
Exclusion Criteria:
1. AF is secondary to electrolyte imbalance, thyroid disease, or a reversible or non-cardiac cause
2. Patient has AF episodes lasting longer than 7 days
3. History of heart surgery, or any previous ablation for AF
4. Myocardial infarction (MI), coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) within preceding 3 months
5. Documented left atrial thrombus on imaging
6. New York Heart Association (NYHA) class III or IV heart failure
7. Hypertrophic obstructive cardiomyopathy
8. Presence of implantable cardioverter defibrillator (ICD)
9. Contraindication to isoproterenol
10. Any other disease or malfunction that would preclude treatment with ablation in the opinion of the investigator
11. Women who are pregnant and/or breast feeding
12. Enrollment in an investigational study evaluating another device, biologic, or drug
Source: ClinicalTrials.gov (NCT03963349). StuddyBuddy aggregates publicly available trial information.