Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study

Stopped early

Conditions studied: Arrythmia

In brief

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).

Key facts

Study ID

NCT03481413

Run by

EPD Solutions, A Philips Company

People needed

566

Starts

2018-11-30

Expected to finish

2023-03-30

Last updated by the study team

2023-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• . Subjects who are eligible for an ablation procedure based on local guidelines,
• . Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
• . Subjects must be able and willing to comply with all follow-up requirements

You may not qualify if…

• . Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
• . Life expectancy less than 12 months,
• . Participation in a concurrent clinical study without prior approval from EPD Solutions.
• . Any contra-indication to use KODEX-EPD System per User Manual.
• . Unrecovered/unresolved adverse events from any previous invasive procedure

Where it is running

• Dignity Health Research Institute — Sacramento, California, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• NYU Langone Health — New York, New York, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Onze Lieve Vrouw Ziekenhuis Aalst — Aalst, Belgium
• AZ Sint Jan — Bruges, Belgium
• Herz- und Diabeteszentrum Nordrhein-Westfalen — Bad Oeynhausen, Germany
• HELIOS Klinikum Erfurt — Erfurt, Germany
• Klinikum Fürth — Fürth, Germany
• Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg) — Hamburg, Germany
• Kardiologische Gemeinschaftspraxis am Park Sanssouci — Potsdam, Germany
• Hadassah University Medical centrum — Jerusalem, Israel
• Shaare Zedek Medical Center — Jerusalem, Israel
• Clinica Montevergine — Mercogliano, Italy
• Monzino Cardiologic Centre, University of Milan. — Milan, Italy
• Catharina Ziekenhuis — Eindhoven, Netherlands
• Maastricht UMC — Maastricht, Netherlands
• Sint Anthonius ziekenhuis — Utrecht, Netherlands
• Fondazione Cardiocentro Ticino — Lugano, Switzerland
• Glenfield Hospital-University of Leicester — Leicester, United Kingdom

Full record on ClinicalTrials.gov

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