Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT04954911
- Lead Sponsor
- Kardium Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Herz- und Diabeteszentrum NRW
🇩🇪Bad Oeynhausen, North Rhine-Westphalia, Germany
Herzzentrum Leipzig
🇩🇪Leipzig, Saxony, Germany