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

NCT ID: NCT03481413

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 566 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-30
• Study Completion Date: 2023-03-30

Brief 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).

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.

Conditions

Arrythmia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Ablation

Ablation therapy for cardiac arrhythmias

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EPD Solutions, A Philips Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anish Amin, MD

Role: PRINCIPAL_INVESTIGATOR

OhioHealth Riverside Methodist Hospital

Yitschak Biton, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Min Tang, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Sciences, Fuwai Hospital

Locations

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

Countries

United States; Belgium; Germany; Israel; Italy; Netherlands; Switzerland; United Kingdom

Other Identifiers

CLN-KODEX-0007

Identifier Type: -

Identifier Source: org_study_id

NCT03619018

Identifier Type: -

Identifier Source: nct_alias