Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center

University Hospital Heidelberg

Status: Active, not recruiting

Conditions: Atrial Fibrillation

Treatments: Device: Pulmonary vein isolation

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05603611

UHHeidelberg_2

Details and patient eligibility

About

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.

Full description

The first patients undergoing PVI by HELIOSTARTM at Heidelberg University Hospital are included in this prospective study. Procedures are performed by an operator proficient in CB-ablation. Procedural outcome was analyzed over the course of increasing experience with the device and in comparison to a previous cohort investigated during implementation of the Arctic FrontTM-cryoballoon (Medtronic).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥18 years, ability to provide informed consent and at least one episode of documented paroxysmal or persistent AF

Exclusion 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