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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Kardium Inc.
Sponsor:
Information provided by (Responsible Party):
Kardium Inc.
ClinicalTrials.gov Identifier:
NCT02168972
First received: June 18, 2014
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

The primary objective of this study is to confirm the procedural safety of the Globe™ mapping and ablation system for the treatment of atrial fibrillation. Secondary objectives include characterization of longer-term safety and performance.


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, Multicentre, 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 early onset device-related serious adverse events [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Rate of early onset device-related serious adverse events within 7 days of the procedure


Secondary Outcome Measures:
  • Rates of device-related adverse events [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    • 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 ] [ 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 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 ] [ Designated as safety issue: No ]
    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 ] [ 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 ]
    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.

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


Estimated Enrollment: 80
Study Start Date: October 2014
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (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 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
  • 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
Germany
Herzzentrum Dresden GmbH Universitätsklinik Not yet recruiting
Dresden, Germany, D-01307
Principal Investigator: Christopher Piorkowski, MD habil.         
Cardioangiologisches Centrum Bethanien Not yet recruiting
Frankfurt/Main, Germany, D-60389
Principal Investigator: Boris Schmidt, MD         
Sub-Investigator: Julian Chun, MD         
Herzzentrum Leipzig GmbH Not yet recruiting
Leipzig, Germany, D-04289
Principal Investigator: Gerhard Hindricks, Prof. MD         
Switzerland
Rhythmologie Klinik Hirslanden Not yet recruiting
Zürich, Switzerland, CH-8032
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: June 19, 2014
Health Authority: Switzerland: Swissmedic
Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Ethikkommission
Germany: Ethics Commission

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 July 20, 2014