Use of dipole density mapping to identify activation in complex supraventricular tachycardias.
The research study was conducted in multiple countries throughout the EU and Canada. The protocol and their corresponding NCT numbers are as follows: NCT01914549 (Protocol CL-SVT-001, Site Belgium, Bruges Dr. Duytschaever = PI) NCT01875614 (Protocol CL-SVT-002, Sites in the UK, Drs. Grace, Hall, \& Schilling = PIs) NCT03368781 (Protocol CL-SVT-004, Site Hamburg, Germany Prof. Willems = PI) NCT02469623 (Protocol CL-SVT-005, Site Prague, Czech Republic Prof. Neuzil = PI) NCT02469636 (Protocol CL-SVT-006, Site Santiago, Chile Dr. Bittner = PI) NCT02469649 (Protocol CL-SVT-008, Site Ontario, Canada Dr. Verma = PI) All of the above records were combined into one as all protocols were essentially identical and one study report was written that encompasses the data/results for all protocols.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
85
AZ Sint-Jan AV Cardiologie
Bruges, Belgium
Southlake Regional Health Center
Newmarket, Ontario, Canada
Pontificia Universidad Catolica de Chile
Santiago, Chile
Na Homolce Hospital
Prague, Czechia
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
Sites reported all adverse events throughout the study follow-up period regardless of their relationship to the device or procedure. Each event was classified and adjudicated by the site-specific investigator. The data were further analyzed by the Sponsor medical reviewer, providing a consistent determination of relationship to device, procedure and the subjects' underlying disease of the atrial arrhythmia condition.
Time frame: 7 days
The Number of Patients for Which Activation Maps Can be Created
The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Time frame: 1 day
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom
Liverpool Heart and Chest Hospital
Liverpool, United Kingdom
Barts Health NHS Trust
Whitechapel, United Kingdom