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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Kardium Inc.
Sponsor:
Information provided by (Responsible Party):
Kardium Inc.
ClinicalTrials.gov Identifier:
NCT02168972
First received: June 18, 2014
Last updated: October 4, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to provide initial 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
    • Unspecified, device-related or possibly device-related SAEs


Secondary Outcome Measures:
  • Subjects presenting with adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • Subjects presenting with serious adverse events up to 1 year
    • Subjects presenting with 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: Up to 1 year ] [ Designated as safety issue: No ]
    Rate of freedom from electrocardiographically documented atrial fibrillation to 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

  • Device functionality [ Time Frame: Intra-procedurally ] [ Designated as safety issue: No ]
    Device mechanical and electrical functionality during procedure


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 [ Time Frame: Intra-procedurally ] [ Designated as safety issue: No ]
    Fluoroscopy time during the procedure


Estimated Enrollment: 10
Study Start Date: October 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a documented history of paroxysmal or persistent atrial fibrillation
  • Indication for ablation according to current ACC/AHA/ESC and HRS/EHRA/ECAS guidelines
  • Between 18 and 80 years of age, inclusive

Exclusion Criteria:

  • Patients with contraindications to open heart surgery
  • 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
  • Patients with known sensitivity to anaesthesia or device components
  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, Ryden 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. No abstract available.

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: October 4, 2014
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
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014