Clinical trial NCT03481413: Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Official title: Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arrythmia
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Acute safety event rate when using the KODEX - EPD System
timeFrame: 7 days
measure: The success rate of the index ablation procedure.
timeFrame: Index procedure
Secondary outcomes:
measure: 12-month safety event rate when the KODEX - EPD System was used in the index ablation procedure and any additional unplanned follow-up procedures.
timeFrame: 12 months
measure: Develop PSOT for cardiac arrhythmia patients.
timeFrame: Index procedure
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Dignity Health Research Institute
state: California
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Columbus
country: United States
facility: OhioHealth Riverside Methodist Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Aalst
country: Belgium
facility: Onze Lieve Vrouw Ziekenhuis Aalst
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum Nordrhein-Westfalen
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Fürth
country: Germany
facility: Klinikum Fürth
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg)
city: Potsdam
country: Germany
facility: Kardiologische Gemeinschaftspraxis am Park Sanssouci
city: Jerusalem
country: Israel
facility: Hadassah University Medical centrum
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Mercogliano
country: Italy
facility: Clinica Montevergine
city: Milan
country: Italy
facility: Monzino Cardiologic Centre, University of Milan.
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht UMC
city: Utrecht
country: Netherlands
facility: Sint Anthonius ziekenhuis
city: Lugano
country: Switzerland
facility: Fondazione Cardiocentro Ticino
city: Leicester
country: United Kingdom
facility: Glenfield Hospital-University of Leicester
Study officials:
affiliation: OhioHealth Riverside Methodist Hospital
name: Anish Amin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Yitschak Biton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Min Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: