Status:
COMPLETED
Pulmonary Vein Isolation Guided by Ablation Index (Ablation Index Registry Study)
Lead Sponsor:
Clinica Mediterranea
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Brief Summary
This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) cath...
Detailed Description
This is a prospective, multi-center, research study designed to evaluate the acute achievement of pulmonary vein (PV) isolation with ThermoCool SmartTouch (ST) and ThermoCool SmartTouch SF (STSF) cath...
Eligibility Criteria
Inclusion
- Subject is indicated for catheter ablation for paroxysmal AF;
- Subject is \> 18 years old;
- Subject is \< 80 years old ;
- Subject is on adequate anticoagulation therapy
Exclusion
- Patients who had already undergo an AF ablation procedure;
- Patients with left ventricular ejection fraction \< 35%
- Women of childbearing potential who are or might be pregnant
- Hematological contraindications to ionizing radiation exposure
- Presence of complex congenital heart disease, and cardiac surgery within 1 month from enrollment
Key Trial Info
Start Date :
November 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 28 2019
Estimated Enrollment :
490 Patients enrolled
Trial Details
Trial ID
NCT03277976
Start Date
November 29 2017
End Date
November 28 2019
Last Update
March 5 2024
Active Locations (1)
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1
Clinica Mediterranea
Naples, Italy