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Completed

NCT Number: NCT04486924

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

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).

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southlake Regional Health Centre, Newmarket, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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

Exclusion criteria

  • 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

Treatment and study plan

Globe Mapping and Ablation System

Device

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

Primary outcomes

  1. Acute isolation of all clinically relevant pulmonary veins confirmed by entrance block

    Time frame: start to end of the procedure

  2. Procedure time

    Time frame: start to end of the procedure

  3. Catheter dwell time

    Time frame: start to end of the procedure

  4. Fluoroscopy time

    Time frame: start to end of the procedure

  5. Fluoroscopy dose area product

    Time frame: start to end of the procedure

  6. Incidence of Primary Adverse Events (PAE) occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure

    Time frame: start to seven days after the end of the procedure

  7. Incidence of all serious adverse events occurring peri-procedurally and within 7 days (inclusive) of the ablation procedure

    Time frame: start to seven days after the end of the procedure

Sponsors and collaborators

Lead sponsor

Kardium Inc.

Industry

Registry information

Official study 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

Acronym: GPS-CA

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 27, 2020
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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