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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-26

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Pulmonary vein isolation

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No