Status:
COMPLETED
Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
Lead Sponsor:
Kardium Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- ≥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
- 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
Key Trial Info
Start Date :
April 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2022
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04486924
Start Date
April 5 2021
End Date
August 30 2022
Last Update
February 10 2023
Active Locations (2)
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1
Southlake Regional Health Centre
Newmarket, Canada
2
St. Paul's Hospital
Vancouver, Canada