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

NCT02168972 | Completed

• 1 other identifier: DOC-19996
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 2

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.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; global; radiofrequency RF ablation; left atrium anatomical and electrophysiological mapping

Outcome Measures

Primary Outcomes (1)

• Rate of subjects presenting pre-defined serious adverse events occurring within 7 days of the procedure

  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

  7 days

Secondary Outcomes (4)

• Subjects presenting with adverse events

  Up to 1 year

• Acute procedural success

  Intra-procedurally

• Rate of freedom from documented atrial fibrillation

  Between 3 months and 1 year

• Change in Quality of life and AF symptom frequency and severity scores

  Up to 1 year

Other Outcomes (4)

• Procedure time

  Intra-procedurally

• Repeat ablation rate

  Up to 1 year

• Fluoroscopy time and dose area product

  Intra-procedurally

Study Arms (1)

Global mapping and ablation device

EXPERIMENTAL

Device: Global mapping and ablation device

Interventions

Global mapping and ablation device 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.

Also known as: Globe® Mapping and Ablation System

Global mapping and ablation device

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kardium Inc.: lead

Study Sites (2)

Herzzentrum Leipzig GmbH

Leipzig, Saxony, D-04289, Germany

Location

Klinik Hirslanden

Zurich, CH-8032, Switzerland

Location

Related Publications (3)

• 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. No abstract available.

  PMID: 22386883 BACKGROUND

• Cappato R, Calkins H, Chen SA, Davies W, Iesaka Y, Kalman J, Kim YH, Klein G, Natale A, Packer D, Skanes A, Ambrogi F, Biganzoli E. Updated worldwide survey on the methods, efficacy, and safety of catheter ablation for human atrial fibrillation. Circ Arrhythm Electrophysiol. 2010 Feb;3(1):32-8. doi: 10.1161/CIRCEP.109.859116. Epub 2009 Dec 7.

  PMID: 19995881 BACKGROUND

• 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. doi: 10.1016/j.jacc.2006.07.009. No abstract available.

  PMID: 16904574 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Hans Kottkamp, Prof.Dr.med.

  Klinik Hirslanden, Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: November 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: August 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-10

Locations

DE (1); CH (1)