Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03481413
Other study ID # CLN-KODEX-0007
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT00376532 - Extracellular Matrix Marker of Arrhythmia Risk (EMMA) N/A
Recruiting NCT04848844 - The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)
Completed NCT06039397 - The Effect of Semi Fowler 30' Right Lateral on Cardiac Output in Acute Heart Failure N/A
Completed NCT04025762 - 24/7 Closed-loop in Older Subjects With Type 1 Diabetes N/A
Not yet recruiting NCT03619018 - All Inclusive KODEX - EPD™ Study Patient Specific Optimized Therapy (PSOT) Study
Completed NCT03786640 - Abbott Brady 3T MRI PMCF
Recruiting NCT05932602 - AVEIR DR Coverage With Evidence Development (CED) Study
Recruiting NCT05935007 - Aveir DR Real-World Evidence Post-Approval Study
Recruiting NCT01988064 - Face to Face vs. Group Training Methods on Pulse Rate Taking in Patients With Cardiovascular Diseases. N/A
Recruiting NCT06310707 - Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter N/A
Recruiting NCT05443321 - Advancing Health Information Exchange (HIE) During Inter-hospital Transfer (IHT) to Improve Patient Outcomes N/A
Recruiting NCT03801681 - ARrhythmias in MYocarditis
Completed NCT03628534 - SERF VT Ablation Early Feasibility Study (EFS) N/A
Recruiting NCT05034432 - The PIVATAL Study -Study of Ventricular Arrhythmia (VTA) Ablation in Left Ventricular Assist Device (LVAD) Patients Phase 4
Recruiting NCT04856267 - Exploration of Arrhythmia Burden in Cardiac Amyloidosis Using Implantable Loop Recorders
Not yet recruiting NCT06414447 - Electrocardiogram (ECG) Validation Study
Completed NCT02401659 - Importance of Patient´s Satisfaction With Telemedicine Based on Monitoring Systems N/A
Recruiting NCT05790642 - Comparison of Different Non-invasive Methods to Assess Pulse Wave Analysis
Recruiting NCT04833712 - Stereotactic Radioablation for the Treatment of Refractory Atrial Fibrillation N/A
Recruiting NCT06371937 - iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease