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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05603611

Enrollment

Registered

2022-11-02

Start date

2021-10-26

Completion date

2022-12-30

Last updated

2022-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

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).

Interventions

DEVICEPulmonary vein isolation

Local electrical isolation of PV ostia to prevent recurrence of AF due to ectopic PV-triggers

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Procedure duration	Day of index procedure, number of minutes	—
LA dwell time	Day of index procedure, number of minutes	Minutes
Fluoroscopy duration	Day of index procedure, number of minutes	Minutes

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026