Status:
TERMINATED
Safety and Efficacy of Pulsed-field Ablation for Atrial Fibrillation in High Versus Low-volume Ablation Centers (SAFFICIENT)
Lead Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-85 years
Brief Summary
Catheter ablation using radiofrequency (RF) energy has been widely adopted for management of atrial fibrillation (AF) for the past several years. However, heterogeneity of outcomes and complication r...
Detailed Description
Prospective, non-randomized, multi-center study NUMBER OF STUDY CENTERS: Up to 80 TRIAL OBJECTIVE To evaluate safety of the VARIPULSE™ Catheter when used in conjunction with the TRUPULSE™ Generator fo...
Eligibility Criteria
Inclusion
- Age: \>≥18 years
- Symptomatic Paroxysmal or Persistent AF patients of ≤ 1 year
- First ablation or redo procedure to treat AF
- Willing to provide written informed consent
- Able and willing to comply with all testing and requirements
Exclusion
- Long-standing persistent AF Page 17 of 70
- Any condition contraindicating chronic anticoagulation
- Prosthetic mechanical valves
- Recent MI (in \<3 months)
- Active systemic infection
- Pregnant or lactating women
- Current enrollment in an investigational study evaluating another device or drug.
- Documented left atrial (LA) thrombus by imaging within 48 hours before procedure (computed tomography (CT), transesophageal echocardiogram (TEE), or intracardiac echocardiogram (ICE) at the beginning of the procedure).
- Uncontrolled heart failure or New York Heart Association (NYHA) Class IV
- Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- Life expectancy less than 12 months
Key Trial Info
Start Date :
August 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 4 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06488820
Start Date
August 29 2024
End Date
April 4 2025
Last Update
May 28 2025
Active Locations (1)
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1
Texas Cardiac Arrhythmia
Austin, Texas, United States, 78705