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

NCT04954911 | Completed

• 1 other identifier: DOC-138528
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Radiofrequency RF Ablation; Globe Mapping and Ablation System

Outcome Measures

Primary Outcomes (3)

• Freedom from AF at 12 months following ablation with the Globe System

  Up to 1 year

• Freedom from AF/AFL/AT at 12 months following ablation with the Globe System

  Up to 1 year

• Device- and procedure-related adverse events within 12 months following ablation with the Globe System

  Up to 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Contraindication for catheter ablation with the Globe System
• Participant is currently participating in an investigational study that would interfere with registry endpoints according to the participating physician's discretion.
• 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.

Sponsors & Collaborators

• Kardium Inc.: lead

Study Sites (2)

Herz- und Diabeteszentrum NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Herz- und Diabeteszentrum NRW

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: November 2, 2021
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Locations

DE (2)