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

Arrythmia Clinical Trial

— PSOT-PMCF  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03481413
• Other study ID #: CLN-KODEX-0007
• Status: Terminated
• Start date: November 30, 2018
• Est. completion date: March 30, 2023

Study information

• Verified date: June 2023
• Source: EPD Solutions, A Philips Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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).

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.

Other known NCT identifiers

• NCT03619018

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 566
• Est. completion date: March 30, 2023
• Est. primary completion date: March 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia

Intervention

Device:
• Ablation
Ablation therapy for cardiac arrhythmias

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis Aalst	Aalst
Belgium	AZ Sint Jan	Brugge
Germany	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
Israel	Hadassah University Medical centrum	Jerusalem
Israel	Shaare Zedek Medical Center	Jerusalem
Italy	Clinica Montevergine	Mercogliano
Italy	Monzino Cardiologic Centre, University of Milan.	Milan
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Maastricht UMC	Maastricht
Netherlands	Sint Anthonius ziekenhuis	Utrecht
Switzerland	Fondazione Cardiocentro Ticino	Lugano
United Kingdom	Glenfield Hospital-University of Leicester	Leicester
United States	Johns Hopkins University	Baltimore	Maryland
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	OhioHealth Riverside Methodist Hospital	Columbus	Ohio
United States	NYU Langone Health	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Dignity Health Research Institute	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
EPD Solutions, A Philips Company

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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