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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486924
• Other study ID #: DOC-150565
• Status: Completed
• Phase: N/A
• Start date: April 5, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2023
• Source: Kardium Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Globe Mapping and Ablation System
Prospective, non-randomized, open-label clinical study.

Locations

Country	Name	City	State
Canada	Southlake Regional Health Centre	Newmarket
Canada	St. Paul's Hospital	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
Kardium Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block		start to end of the procedure
Primary	Procedure time		start to end of the procedure
Primary	Catheter dwell time		start to end of the procedure
Primary	Fluoroscopy time		start to end of the procedure
Primary	Fluoroscopy dose area product		start to end of the procedure
Primary	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
Primary	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