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

NCT04486924 | Completed

• 1 other identifier: DOC-150565
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (7)

• 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

• Catheter dwell time

  start to end of the procedure

• Fluoroscopy time

  start to end of the procedure

• Fluoroscopy dose area product

  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

• 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

Study Arms (1)

Globe Mapping and Ablation System

EXPERIMENTAL

Device: Globe Mapping and Ablation System

Interventions

Globe Mapping and Ablation System DEVICE

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

Globe Mapping and Ablation System

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years old and ≤75 years old
• 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.
• Selected for catheter ablation for the treatment of atrial fibrillation

You may not qualify if:

• History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• 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)
• Presence of LA thrombus by TEE, CT scan, MRI, or angiography
• 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)
• Planned concomitant cardiac surgery procedures besides AF treatment (valve, coronary, others)
• Uncontrolled heart failure or NYHA Class III or IV heart failure
• Valve repair or replacement or presence of a prosthetic valve
• Coronary artery bypass grafting, cardiac surgery, or valvular cardiac surgical procedure within the past 6 months
• MI or PCI procedure within 3 months before screening
• Left Ventricular Ejection Fraction (LVEF) \< 40%
• Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD)
• Severe pulmonary hypertension or prior pulmonary stenting
• History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment
• Contraindication to anticoagulation (e.g., heparin)
• History of blood clotting or bleeding disease

Sponsors & Collaborators

• Kardium Inc.: lead

Study Sites (2)

Southlake Regional Health Centre

Newmarket, Canada

Location

St. Paul's Hospital

Vancouver, Canada

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Southlake Regional Health Centre

  596 Davis Dr, Newmarket ON L3Y 2P9, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: April 5, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: February 10, 2023

Record last verified: 2023-02

Locations

CA (2)