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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2016 by Kardium Inc.
Sponsor:
Information provided by (Responsible Party):
Kardium Inc.
ClinicalTrials.gov Identifier:
NCT02168972
First received: June 18, 2014
Last updated: February 3, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Atrial Fibrillation
Device: Global mapping and ablation device

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Kardium Inc.:

Primary Outcome Measures:
  • Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

    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
    • Intra-procedural device complication requiring open chest or heart surgery
    • Death


Secondary Outcome Measures:
  • Subjects presenting with adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Other Outcome Measures:
  • Procedure time [ Time Frame: Intra-procedurally ] [ Designated as safety issue: No ]
    Procedure time

  • Repeat ablation rate [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Rate of repeat ablation with a third party catheter or the Globe system

  • Fluoroscopy time and dose area product [ Time Frame: Intra-procedurally ] [ Designated as safety issue: No ]
    Fluoroscopy time and dose area product during the procedure

  • Device functionality [ Time Frame: Intra-procedurally ] [ Designated as safety issue: No ]
    Rate of procedures terminated or switched to a third-party ablation catheter due to Globe device failures


Estimated Enrollment: 60
Study Start Date: November 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Global mapping and ablation device 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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients indicated for ablation, with a documented history of symptomatic paroxysmal or persistent 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02168972

Locations
Switzerland
Klinik Hirslanden Recruiting
Zürich, Switzerland, CH-8032
Contact: Hans Kottkamp, Prof. Dr. med.    +41 44 387 20 00    rhythmologie.hirslanden@hirslanden.ch   
Principal Investigator: Hans Kottkamp, Prof. MD         
Sponsors and Collaborators
Kardium Inc.
  More Information

Publications:
Calkins H, Kuck KH, Cappato R, Brugada J, Camm AJ, Chen SA, Crijns HJ, Damiano RJ Jr, Davies DW, DiMarco J, Edgerton J, Ellenbogen K, Ezekowitz MD, Haines DE, Haissaguerre M, Hindricks G, Iesaka Y, Jackman W, Jalife J, Jais P, Kalman J, Keane D, Kim YH, Kirchhof P, Klein G, Kottkamp H, Kumagai K, Lindsay BD, Mansour M, Marchlinski FE, McCarthy PM, Mont JL, Morady F, Nademanee K, Nakagawa H, Natale A, Nattel S, Packer DL, Pappone C, Prystowsky E, Raviele A, Reddy V, Ruskin JN, Shemin RJ, Tsao HM, Wilber D; Heart Rhythm Society Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. 2012 HRS/EHRA/ECAS expert consensus statement on catheter and surgical ablation of atrial fibrillation: recommendations for patient selection, procedural techniques, patient management and follow-up, definitions, endpoints, and research trial design: a report of the Heart Rhythm Society (HRS) Task Force on Catheter and Surgical Ablation of Atrial Fibrillation. Developed in partnership with the European Heart Rhythm Association (EHRA), a registered branch of the European Society of Cardiology (ESC) and the European Cardiac Arrhythmia Society (ECAS); and in collaboration with the American College of Cardiology (ACC), American Heart Association (AHA), the Asia Pacific Heart Rhythm Society (APHRS), and the Society of Thoracic Surgeons (STS). Endorsed by the governing bodies of the American College of Cardiology Foundation, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, the Asia Pacific Heart Rhythm Society, and the Heart Rhythm Society. Heart Rhythm. 2012 Apr;9(4):632-696.e21. doi: 10.1016/j.hrthm.2011.12.016. Epub 2012 Mar 1.
European Heart Rhythm Association; Heart Rhythm Society, Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Zamorano JL; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation. ACC/AHA/ESC 2006 guidelines for the management of patients with atrial fibrillation--executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation). J Am Coll Cardiol. 2006 Aug 15;48(4):854-906. Erratum in: J Am Coll Cardiol. 2007 Aug 7;50(6):562..

Responsible Party: Kardium Inc.
ClinicalTrials.gov Identifier: NCT02168972     History of Changes
Other Study ID Numbers: DOC-19996 
Study First Received: June 18, 2014
Last Updated: February 3, 2016
Health Authority: Switzerland: Swissmedic
Switzerland: Ethikkommission

Keywords provided by Kardium Inc.:
atrial fibrillation
global
radiofrequency RF ablation
left atrium anatomical and electrophysiological mapping

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 26, 2016