Back to resultsPerformance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation (GPS-CA)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Globe Mapping and Ablation System
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
- ≥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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Southlake Regional Health Centre
- St. Paul's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Globe Mapping and Ablation System
Arm Description
Outcomes
Primary Outcome Measures
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
Procedure time
Catheter dwell time
Fluoroscopy time
Fluoroscopy dose area product
Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04486924
Brief Title
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
Acronym
GPS-CA
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kardium Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Globe Mapping and Ablation System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Globe Mapping and Ablation System
Intervention Description
Prospective, non-randomized, open-label clinical study.
Primary Outcome Measure Information:
Title
Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
Time Frame
start to end of the procedure
Title
Procedure time
Time Frame
start to end of the procedure
Title
Catheter dwell time
Time Frame
start to end of the procedure
Title
Fluoroscopy time
Time Frame
start to end of the procedure
Title
Fluoroscopy dose area product
Time Frame
start to end of the procedure
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Southlake Regional Health Centre
Organizational Affiliation
596 Davis Dr, Newmarket ON L3Y 2P9, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southlake Regional Health Centre
City
Newmarket
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
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