Atrial FibrillationGLOBE-EUNCT04954911
Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
An observational study of Atrial Fibrillation, run by Kardium Inc. at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 6 participants
- Where
- 2 sitesGermany
- Study dates
- 2 Nov 2021to 23 May 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, North Rhine-Westphalia, 32545
Herzzentrum Leipzig
Leipzig, Saxony, 04289
About this study
Official title: Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
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
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF at 12 months following ablation with the Globe System
Measured: Up to 1 year
Freedom from AF/AFL/AT at 12 months following ablation with the Globe System
Measured: Up to 1 year
Device- and procedure-related adverse events within 12 months following ablation with the Globe System
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start2 Nov 2021
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Herz- und Diabeteszentrum NRW, Principal investigator, Klinik für Elektrophysiologie/Rhythmologie Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954911
- Sponsor's protocol ID
- DOC-138528
- Acronym
- GLOBE-EU
- Status last verified
- Sep 2023
- First submitted
- 29 Jun 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-centre, Observational Registry to Evaluate the Clinical Performance of the Globe® Mapping and Ablation System for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04954911
- Acronym / sponsor ID
- GLOBE-EU / DOC-138528
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Radiofrequency RF Ablation, Globe Mapping and Ablation System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Freedom from AF at 12 months following ablation with the Globe System
Time frame: Up to 1 year
Freedom from AF/AFL/AT at 12 months following ablation with the Globe System
Time frame: Up to 1 year
Device- and procedure-related adverse events within 12 months following ablation with the Globe System
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
Related trials for Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruiting
Partial Cardiac Denervation for Preventing Atrial Fibrillation After CABG
Postoperative Atrial Fibrillation, Coronary Artery Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herz- und Diabeteszentrum NRW principal investigator
Klinik für Elektrophysiologie/Rhythmologie Herz- und Diabeteszentrum NRW Universitätsklinik der Ruhr-Universität Bochum
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Kardium Inc. at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF at 12 months following ablation with the Globe System (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.