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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05603611
• Other study ID #: UHHeidelberg_2
• Status: Active, not recruiting
• Start date: October 26, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: October 2022
• Source: University Hospital Heidelberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: October 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Pulmonary vein isolation
Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers

Locations

Country	Name	City	State
Germany	University Hospital Heidelberg, Department of Cardiology	Heidelberg

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Heidelberg	Biosense Webster, Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure duration		Day of index procedure, number of minutes
Primary	LA dwell time	Minutes	Day of index procedure, number of minutes
Primary	Fluoroscopy duration	Minutes	Day of index procedure, number of minutes
Secondary	Short-term AF arrhythmia recurrence	ECG-documented AF	3 months
Secondary	Procedural complications	As diagnosed by physician and documented in written report	3 months
Secondary	Long-term arrhythmia recurrence	ECG-documented AF	12 months