Atrial Fibrillation
Conditions
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).
Interventions
DEVICEGlobe Mapping and Ablation System
Prospective, non-randomized, open-label clinical study.
Sponsors
Kardium Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 years old and ≤75 years old 2. 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. 3. Selected for catheter ablation for the treatment of atrial fibrillation
Exclusion criteria
1. History of previous left atrial ablation or surgical treatment for AF/AFL/AT 2. 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) 3. Presence of LA thrombus by TEE, CT scan, MRI, or angiography 4. 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) 5. Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others) 6. Uncontrolled heart failure or NYHA Class III or IV heart failure 7. Valve repair or replacement or presence of a prosthetic valve 8. Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months 9. MI or PCI procedure within 3 months before screening 10. Left Ventricular Ejection Fraction (LVEF) \< 40% 11. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD) 12. Severe pulmonary hypertension or prior pulmonary stenting 13. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment 14. Contraindication to anticoagulation (e.g., heparin) 15. History of blood clotting or bleeding disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure | start to seven days after the end of the procedure |
| Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block | start to end of the procedure |
| Procedure time | start to end of the procedure |
| Catheter dwell time | start to end of the procedure |
| Fluoroscopy time | start to end of the procedure |
| Fluoroscopy dose area product | start to end of the procedure |
| Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure | start to seven days after the end of the procedure |
Countries
Canada
Outcome results
None listed