NCT05603611

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

Implementation of the HELIOSTARTM in Real-world Clinical Practice at a High-volume Center - Operator Learning Curve and Procedural Outcome Parameters

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University Hospital Heidelberg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Pulmonary vein isolation	Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers

Timeline

• Start date: 2021-10-26
• Primary completion: 2022-10-23
• Completion: 2022-12-30
• First posted: 2022-11-02
• Last updated: 2022-11-02

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study