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

Kardium

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Globe Mapping and Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT04486924

DOC-150565

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Globe Mapping and Ablation System

Experimental group

Treatment:

Device: Globe Mapping and Ablation System