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

NCT ID: NCT04486924

Last Updated: 2023-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-05
• Study Completion Date: 2022-08-30

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).

Conditions

Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Globe Mapping and Ablation System

Group Type: EXPERIMENTAL

Globe Mapping and Ablation System

Intervention Type: DEVICE

Prospective, non-randomized, open-label clinical study.

Interventions

Globe Mapping and Ablation System

Prospective, non-randomized, open-label clinical study.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kardium Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Southlake Regional Health Centre

Role: PRINCIPAL_INVESTIGATOR

596 Davis Dr, Newmarket ON L3Y 2P9, Canada

Locations

Southlake Regional Health Centre

Newmarket, , Canada

St. Paul's Hospital

Vancouver, , Canada

Countries

Canada

Other Identifiers

DOC-150565

Identifier Type: -

Identifier Source: org_study_id