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

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).

Study Overview

• Status: Terminated
• Conditions: Arrythmia
• Intervention / Treatment: Device: Ablation

Detailed 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 Type: Observational
• Enrollment (Actual): 566

Contacts and Locations

• Study Contact: Name: Anneleen Viville; Phone Number: +32479983495; Email: Anneleen.Viville@philips.com

Study Locations

• Belgium
  • Aalst, Belgium
    • Onze Lieve Vrouw Ziekenhuis Aalst
  • Brugge, Belgium
    • AZ Sint Jan
• Germany
  • Bad Oeynhausen, Germany, 32545
    • Herz- und Diabeteszentrum Nordrhein-Westfalen
  • Erfurt, Germany, 99089
    • Helios Klinikum Erfurt
  • Fürth, Germany, 190766
    • Klinikum Fürth
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg)
  • Potsdam, Germany, 14471
    • Kardiologische Gemeinschaftspraxis am Park Sanssouci
• Israel
  • Jerusalem, Israel
    • Shaare Zedek Medical Center
  • Jerusalem, Israel
    • Hadassah University Medical centrum
• Italy
  • Mercogliano, Italy
    • Clinica Montevergine
  • Milan, Italy
    • Monzino Cardiologic Centre, University of Milan.
• Netherlands
  • Eindhoven, Netherlands
    • Catharina Ziekenhuis
  • Maastricht, Netherlands, 6229
    • Maastricht UMC
  • Utrecht, Netherlands
    • Sint Anthonius ziekenhuis
• Switzerland
  • Lugano, Switzerland
    • Fondazione Cardiocentro Ticino
• United Kingdom
  • Leicester, United Kingdom
    • Glenfield Hospital-University of Leicester
• United States
  • California
    • Sacramento, California, United States, 95819
      • Dignity Health Research Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
  • Ohio
    • Columbus, Ohio, United States, 43214
      • OhioHealth Riverside Methodist Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Arrhythmia patients indicated for EP procedures.

Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.

Description

Inclusion Criteria:

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

Exclusion Criteria

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute safety event rate when using the KODEX - EPD System	The primary safety event rate will be measured against a pre-specified performance goal of 12% and include serious system- or procedure-related adverse events occurring within 7 days of the index procedure	7 days
The success rate of the index ablation procedure.	A procedure is defined as successful if the following conditions are met: KODEX - EPD System was the only mapping system used in the index ablation procedure.; The primary arrhythmia was terminated and validated by operators' standard clinical practice (e.g., pacing).	Index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
12-month safety event rate when the KODEX - EPD System was used in the index ablation procedure and any additional unplanned follow-up procedures.	The primary safety event-free rate will be measured against a pre-specified performance goal of 15% and include serious system- or procedure-related adverse events occurring within 12 months from the initial index procedure.	12 months
Develop PSOT for cardiac arrhythmia patients.	PSOT PMCF will find appropriate functions to map predictor variables (e.g., subject demographics, arrhythmia type, ablation energy source, etc.) to target variables (e.g., procedure success, adverse events, etc.) with the goal of improving efficacy and minimizing adverse events for future cardiac arrythmia subjects.	Index procedure

Collaborators and Investigators

• Sponsor: EPD Solutions, A Philips Company
• Investigators: Principal Investigator: Anish Amin, MD, OhioHealth Riverside Methodist Hospital; Principal Investigator: Yitschak Biton, MD, Hadassah Medical Organization; Principal Investigator: Min Tang, MD, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2018
• Primary Completion (Actual): March 30, 2023
• Study Completion (Actual): March 30, 2023

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 27, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: CLN-KODEX-0007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No