Safety and Performance of a GLOBAL Mapping and Ablation Device for the Treatment of Atrial Fibrillation (GLOBAL-AF)
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.
|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|
- 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
- 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
- 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.
|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)|
|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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02168972
|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|
|Rhythmologie Klinik Hirslanden||Not yet recruiting|
|Zürich, Switzerland, CH-8032|
|Principal Investigator: Hans Kottkamp, Prof. MD|