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Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study — PSOT-PMCF  

Arrythmia Clinical Trial

Official title:
Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study

Clinical Trial Summary

Study to evaluate the safety and procedural performance of the KODEX - EPD System when used in the treatment of cardiac arrhythmias. An additional objective is to develop patient specific optimized therapy (PSOT PMCF) via machine learning to improve future treatment of cardiac arrhythmias (PSOT).

Clinical Trial Description

PSOT PMCF is a prospective, multi-center, non-randomized, open label, single arm observational/ registry clinical study. Consented subjects who are scheduled to undergo an ablation procedure due to an arrhythmia will be enrolled in the clinical study. The clinical study consists of a standard-of-care index ablation procedure and following up subjects for 12 months to evaluate product safety. The index ablation procedure will be performed using the KODEX - EPD System in conjunction with compatible therapeutic and diagnostic catheters. Electrophysiologists should follow current, local, and expert consensus guidelines when treating subjects. The PSOT Sub-Study Secondary System is a sub-study of the PSOT PMCF study. The objective of the sub-study is to collect data for the evaluation of the performance of new software features via a secondary system in subjects undergoing standard of care catheter-based endocardial mapping for cardiac arrhythmia's using a commercial KODEX EPD Mapping System. The KODEX-EPD system in this clinical investigation will have a Primary/Secondary configuration. Data collection and processing will be done on the Primary system in the interventional lab with market released software and the Primary system will be used to guide therapy. Data from the Primary system will be transferred to a second (Secondary) workstation in the control/observation room via unidirectional communication and data on the Secondary system will be processed with non-released software. Results from this sub-study will be used to support the development and refinement of new software features. It is not the purpose of this sub-study to obtain CE mark. The primary endpoint of the sub-study is data collection of the KODEX-EPD non-released features from a secondary system. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03481413
Study type Observational [Patient Registry]
Source EPD Solutions, A Philips Company
Contact
Status Terminated
Phase
Start date November 30, 2018
Completion date March 30, 2023
View Details
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