Dipole Density Mapping in Supraventricular Tachycardia

Not Applicable

Completed

Interventions: Device: Dipole Density Mapping with AcQMap followed by ablation

Brief Summary: Use of dipole density mapping to identify activation in complex supraventricular tachycardias.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Dipole Density Mapping	Dipole Density Mapping with AcQMap followed by ablation	-

Primary Outcome Measures

Name	Time	Method
The Number of Patients for Which Activation Maps Can be Created	1 day	The primary performance endpoint was the number of subjects with successful construction of pre- and post-ablation procedure activation maps.
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events	7 days	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.

Secondary Outcome Measures

Name	Time	Method

Locations (8): Pontificia Universidad Catolica de Chile
🇨🇱
Santiago, Chile
Papworth Hospital NHS Foundation Trust
🇬🇧
Cambridge, United Kingdom
Liverpool Heart and Chest Hospital
🇬🇧
Liverpool, United Kingdom
Elektrophysiologie Universitätsklinikum Hamburg-Eppendorf
🇩🇪
Hamburg, Germany
Barts Health NHS Trust
🇬🇧
Whitechapel, United Kingdom
Southlake Regional Health Center
🇨🇦
Newmarket, Ontario, Canada
AZ Sint-Jan AV Cardiologie
🇧🇪
Bruges, Belgium
Na Homolce Hospital
🇨🇿
Prague, Czechia