Performance and Safety of the Globe® Mapping and Ablation System With the GPS™ Module for the Treatment of Atrial Fibrillation

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Globe Mapping and Ablation System

• Registration Number: NCT04486924
• Lead Sponsor: Kardium Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-22
• Study First Submitted QC: 2020-07-22
• Study First Posted: 2020-07-27
• Study Start: 2021-04-05
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Globe Mapping and Ablation System	Globe Mapping and Ablation System	-

Primary Outcome Measures

Name	Time	Method
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
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
Fluoroscopy time	start to end of the procedure
Fluoroscopy dose area product	start to end of the procedure
Catheter dwell time	start to end of the procedure
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

Trial Locations

Locations (2)

Southlake Regional Health Centre; 🇨🇦 Newmarket, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, Canada