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Active Not Recruiting
NCT05603611
Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center
Conditions: Atrial Fibrillation
Sex: All
Ages: 18 Years – N/A
Enrollment: 40
Sponsor: University Hospital Heidelberg
Location: Germany
Summary
The HELIOSTARTM catheter (Biosense Webster) is a new technology for pulmonary vein isolation (PVI) in atrial fibrillation (AF), combining radiofrequency (RF)-ablation and 3D-mapping visualization with the concept of "single-shot"-ablation device.
This study evaluates the operator learning curve und procedural outcome during implementation of the HELIOSTARTM.
Eligibility Criteria
Inclusion Criteria:age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AFExclusion Criteria:history of prior AF ablation, left atrial thrombus, suspected irregular PV-anatomy in pre-procedural transesophageal echocardiography (TOE) or contraindication for peri-procedural anticoagulation therapy
Source: ClinicalTrials.gov (NCT05603611). StuddyBuddy aggregates publicly available trial information.
