Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation

NCT ID: NCT04954911

Last Updated: 2023-09-18

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

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-02

Study Completion Date

2023-05-23

Brief Summary

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This is an observational, multicentre, prospective, post-market product registry for participants with AF for whom ablation by the commercially available Globe Mapping and Ablation System was indicated before enrolment into the registry. The aim of the registry is to confirm the clinical performance and safety of the Globe Mapping and Ablation System in a real-life setting.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 years or older
2. Participants with a documented history of atrial fibrillation indicated for ablation using the Globe Mapping and Ablation System before enrolment into registry
3. Signed informed consent

Exclusion Criteria

1. Contraindication for catheter ablation with the Globe System
2. Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
3. Physical or mental condition because of which, in the opinion of the physician, the participant is not able to give informed consent or comply with physician instructions.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kardium Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herz- und Diabeteszentrum NRW

Role: PRINCIPAL_INVESTIGATOR

Klinik für Elektrophysiologie/Rhythmologie Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum

Locations

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Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status

Herzzentrum Leipzig

Leipzig, Saxony, Germany

Site Status

Countries

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Germany

Other Identifiers

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DOC-138528

Identifier Type: -

Identifier Source: org_study_id

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