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

Active, not recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT05603611
• Lead Sponsor: University Hospital Heidelberg

Brief 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).

Study Timeline

• Study Start: 2021-10-26
• Status Verified: 2022-10
• Primary Completion: 2022-10-23
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-31
• Last Update Submitted: 2022-10-31
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Procedure duration	Day of index procedure, number of minutes
Fluoroscopy duration	Day of index procedure, number of minutes	Minutes
LA dwell time	Day of index procedure, number of minutes	Minutes

Secondary Outcome Measures

Name	Time	Method
Procedural complications	3 months	As diagnosed by physician and documented in written report
Short-term AF arrhythmia recurrence	3 months	ECG-documented AF
Long-term arrhythmia recurrence	12 months	ECG-documented AF

Trial Locations

Locations (1)

University Hospital Heidelberg, Department of Cardiology; 🇩🇪 Heidelberg, Germany