Clinical trial NCT04486924: Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Kardium Inc.
Sponsor class: INDUSTRY
First posted: 2020-07-27
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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).


Eligibility criteria: 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

Primary outcomes:
measure: Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block
timeFrame: start to end of the procedure
measure: Procedure time
timeFrame: start to end of the procedure
measure: Catheter dwell time
timeFrame: start to end of the procedure
measure: Fluoroscopy time
timeFrame: start to end of the procedure
measure: Fluoroscopy dose area product
timeFrame: start to end of the procedure
measure: Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
timeFrame: start to seven days after the end of the procedure
measure: Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure
timeFrame: start to seven days after the end of the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
city: Vancouver
country: Canada
facility: St. Paul's Hospital
Study officials:
affiliation: 596 Davis Dr, Newmarket ON L3Y 2P9, Canada
name: Southlake Regional Health Centre
role: PRINCIPAL_INVESTIGATOR
References: