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Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF) (GLOBAL-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168972
Recruitment Status : Completed
First Posted : June 20, 2014
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Kardium Inc.

Tracking Information
First Submitted Date  ICMJE June 18, 2014
First Posted Date  ICMJE June 20, 2014
Last Update Posted Date October 2, 2019
Actual Study Start Date  ICMJE November 2014
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 24, 2016)
Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure [ Time Frame: 7 days ]
Rate of subjects presenting with one or more of the following serious adverse events occurring within 7-days of the procedure:
  • Transient ischemic attack
  • Cerebrovascular accident
  • Major bleeding
  • Cardiac tamponade
  • Pulmonary vein stenosis
  • Pericarditis
  • Myocardial infarction
  • Diaphragmatic paralysis
  • Atrio-esophageal fistula
  • Valvular damage
  • Phrenic nerve palsy
  • Intra-procedural device complication requiring open chest or heart surgery
  • Death
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
Rate of early onset device-related serious adverse events [ Time Frame: 7 days ]
Rate of early onset device-related serious adverse events within 7 days of the procedure
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • Subjects presenting with adverse events [ Time Frame: Up to 1 year ]
    • Subjects presenting with primary serious adverse events up to 1 year
    • Subjects presenting with adverse events or serious adverse events up to 1 year
  • Acute procedural success [ Time Frame: Intra-procedurally ]
    Acute device performance in achieving entrance block of the pulmonary veins
  • Rate of freedom from documented atrial fibrillation [ Time Frame: Between 3 months and 1 year ]
    Rate of freedom from electrocardiographically documented atrial fibrillation between 3 months and 1 year post-ablation
  • Change in Quality of life and AF symptom frequency and severity scores [ Time Frame: Up to 1 year ]
    Change of quality of life (SF-36) and AF symptom frequency and severity (Bubien et al 1993) questionnaire scores from baseline to 1 year after ablation
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2014)
  • Rates of device-related adverse events [ Time Frame: Up to 1 year ]
    • Device-related SAE rate up to 1 year
    • Device-related AE rate up to 1 year
    • Rate of symptomatic, moderate-to-severe PV stenosis
  • Acute procedural success [ Time Frame: Intra-procedurally ]
    Acute device performance in achieving entrance block of the pulmonary veins
  • Rate of freedom from documented atrial fibrillation [ Time Frame: Up to 1 year ]
    Rate of freedom from atrial fibrillation after single ablation procedure and after repeat ablation procedure, based on electrocardiographic data through 12 months post-ablation, evaluated at each study visit after a 3-month blanking period
  • Change in Quality of life and AF symptom frequency and severity scores [ Time Frame: Up to 1 year ]
    Change from baseline of patient-reported quality of life (SF-36) and AF symptom frequency and severity (Bubien et al 1993) questionnaire scores, up to 1 year after ablation
  • Device functionality [ Time Frame: Intra-procedurally ]
    Device mechanical and electrical functionality during procedure
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2016)
  • Procedure time [ Time Frame: Intra-procedurally ]
    Procedure time
  • Repeat ablation rate [ Time Frame: Up to 1 year ]
    Rate of repeat ablation with a third party catheter or the Globe system
  • Fluoroscopy time and dose area product [ Time Frame: Intra-procedurally ]
    Fluoroscopy time and dose area product during the procedure
  • Device functionality [ Time Frame: Intra-procedurally ]
    Rate of procedures terminated or switched to a third-party ablation catheter due to Globe device failures
Original Other Pre-specified Outcome Measures
 (submitted: June 18, 2014)
  • Procedure and fluoroscopy time [ Time Frame: Intra-procedurally ]
    Procedure and fluoroscopy time.
  • Repeat ablation rate [ Time Frame: Up to 1 year ]
    Repeat ablation rate measured as the number of subjects who received repeated ablation divided by the total number of subjects treated with the Globe system.
 
Descriptive Information
Brief Title  ICMJE Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)
Official Title  ICMJE A Prospective, Non-randomized Clinical Study to Assess Safety and Performance of a Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
Brief Summary The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe® Mapping and Ablation System for treating patients with atrial fibrillation.
Detailed Description Upon successful enrolment, subjects will be scheduled for mapping and radiofrequency (RF) ablation. Cardiac CT imaging, echocardiography and baseline 12-lead ECG will be performed pre-procedure for screening and health assessment. During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the left atrium (LA) will be followed by RF ablation to achieve pulmonary vein isolation (PVI). Additional lesions will be created as deemed appropriate by the investigator. Intracardiac electrogram mapping will be used to confirm PVI during the procedure. Echocardiography will be performed at discharge to assess cardiac function. Electrocardiograms by 12-lead ECG and 7-day Holter monitoring will be recorded at discharge, and 3, 6 and 12 months after treatment. Follow-up assessments will be performed at discharge, 7 days, and 1, 3, 6 and 12 months after treatment, to track freedom from documented AF and adverse events. Subject-reported AF symptomology and quality of life will also be assessed during follow-up.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atrial Fibrillation
Intervention  ICMJE Device: Global mapping and ablation device
During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.
Other Name: Globe® Mapping and Ablation System
Study Arms  ICMJE Experimental: Global mapping and ablation device
Intervention: Device: Global mapping and ablation device
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 3, 2016)
60
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2014)
80
Actual Study Completion Date  ICMJE August 2019
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients indicated for ablation, with a documented history of symptomatic paroxysmal atrial fibrillation
  • Between 18 and 80 years of age, inclusive

Exclusion Criteria:

  • Patients who have contraindications to open heart surgery
  • Patients from an Intensive Care Unit
  • Patients requiring concurrent right atrial ablation or who have had previous left atrial ablation
  • Previous cardiac procedure or known abnormalities that would interfere with device delivery, position, or treatment efficacy
  • History of a documented thromboembolic event or bleeding abnormalities
  • Contraindication to anticoagulation therapy
  • Mental impairment or other conditions, which may not allow patient to understand the nature, significance and scope of the study
  • Anatomy that would prevent safe and appropriate introduction or delivery of the Globe device into the patient
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02168972
Other Study ID Numbers  ICMJE DOC-19996
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kardium Inc.
Study Sponsor  ICMJE Kardium Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hans Kottkamp, Prof.Dr.med. Klinik Hirslanden, Zurich
PRS Account Kardium Inc.
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP