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

NCT05603611 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2022-11-02

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Pulmonary vein isolation

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

Sponsors & Collaborators

  • Biosense Webster, Inc.

    collaborator INDUSTRY

  • University Hospital Heidelberg

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-26
Primary Completion
2022-10-23
Completion
2022-12-30
FDA Device
Yes

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05603611 on ClinicalTrials.gov