Atrial FibrillationGPS-CANCT04486924
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
A study testing Globe Mapping and Ablation System in people with Atrial Fibrillation, run by Kardium Inc. at 2 sites in Canada.
Trial summary
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Globe Mapping and Ablation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Apr 2021to 30 Aug 2022
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old and ≤75 years old
- Symptomatic AF with at least one AF episode electrocardiographically documented within one (1) year prior to enrolment. Documentation may include diagnosis in the patient medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter monitor or telemetry strip.
- Selected for catheter ablation for the treatment of atrial fibrillation
Who cannot join
- History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy)
- Presence of LA thrombus by TEE, CT scan, MRI, or angiography
- Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity)
- Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
- Uncontrolled heart failure or NYHA Class III or IV heart failure
Show all 15Show fewer
- Valve repair or replacement or presence of a prosthetic valve
- Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months
- MI or PCI procedure within 3 months before screening
- Left Ventricular Ejection Fraction (LVEF) < 40%
- Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)
- Severe pulmonary hypertension or prior pulmonary stenting
- History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
- Contraindication to anticoagulation (e.g., heparin)
- History of blood clotting or bleeding disease
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Southlake Regional Health Centre
Newmarket
St. Paul's Hospital
Vancouver
About this study
Official title: Evaluation of the Acute Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
This study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
- Conditions
- Atrial Fibrillation
- Being tested
- Globe Mapping and Ablation System
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Globe Mapping and Ablation SystemDevice
Prospective, non-randomized, open-label clinical study.
| Study group | Role | What they receive |
|---|---|---|
| Globe Mapping and Ablation System | Experimental | Not described Receives: Device: Globe Mapping and Ablation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
Measured: start to end of the procedure
Procedure time
Measured: start to end of the procedure
Catheter dwell time
Measured: start to end of the procedure
Fluoroscopy time
Measured: start to end of the procedure
Fluoroscopy dose area product
Measured: start to end of the procedure
Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Measured: start to seven days after the end of the procedure
Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Measured: start to seven days after the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start5 Apr 2021
- Primary completion30 Aug 2022
- Study completion30 Aug 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kardium Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Southlake Regional Health Centre, Principal investigator, 596 Davis Dr, Newmarket ON L3Y 2P9, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486924
- Sponsor's protocol ID
- DOC-150565
- Acronym
- GPS-CA
- Status last verified
- Feb 2023
- First submitted
- 22 Jul 2020
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Acute Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT04486924
- Acronym / sponsor ID
- GPS-CA / DOC-150565
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Kardium Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 27 Jul 2020 (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 study will evaluate the safety and acute performance of the Globe® Mapping and Ablation System with the GPS™ Module intended to conduct electroanatomic mapping and ablation treatment of subjects with atrial fibrillation (AF).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globe Mapping and Ablation System | Experimental | Device: Globe Mapping and Ablation System |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old and ≤75 years old
- Symptomatic AF with at least one AF episode electrocardiographically documented within one (1) year prior to enrolment. Documentation may include diagnosis in the patient medical files, electrocardiogram (ECG), Trans-telephonic monitoring (TTM), Holter monitor or telemetry strip.
- Selected for catheter ablation for the treatment of atrial fibrillation
Key exclusion criteria (15 listed)
- History of previous left atrial ablation or surgical treatment for AF/AFL/AT
- Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, previous cardiac tamponade, pleural adhesions, and prior thoracotomy)
- Presence of LA thrombus by TEE, CT scan, MRI, or angiography
- Known conditions or anatomical abnormality that may interfere with the device delivery or positioning (e.g. myxoma, tumour, calcification, venous access path narrowing, or tortuosity)
- Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Globe Mapping and Ablation SystemProspective, non-randomized, open-label clinical study. | Device | Globe Mapping and Ablation System |
Primary outcome
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
Time frame: start to end of the procedure
Procedure time
Time frame: start to end of the procedure
Catheter dwell time
Time frame: start to end of the procedure
Fluoroscopy time
Time frame: start to end of the procedure
Fluoroscopy dose area product
Time frame: start to end of the procedure
Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Time frame: start to seven days after the end of the procedure
Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Time frame: start to seven days after the end of the procedure
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 10 Feb 2023.
Related trials for Atrial Fibrillation
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Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Southlake Regional Health Centre principal investigator
596 Davis Dr, Newmarket ON L3Y 2P9, Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Globe Mapping and Ablation System in people with Atrial Fibrillation, run by Kardium Inc. at 2 sites in Canada.
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 15 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 10 Feb 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 Canada. 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?
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block (time frame: start to end of the procedure). The study lists 7 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 10 Feb 2023.