ArrythmiaPSOT-PMCFNCT03481413
Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
An observational study of Arrythmia, run by EPD Solutions, A Philips Company at 22 sites in 8 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrythmia
- What is being tested?
- Ablation
- Type of treatment
- Medical device
- How many people
- 566 participants
- Where
- 22 sitesin 8 countries
- Study dates
- 30 Nov 2018to 30 Mar 2023
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- . Subjects who are eligible for an ablation procedure based on local guidelines,
- . Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
- . Subjects must be able and willing to comply with all follow-up requirements
Who cannot join
- . Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
- . Life expectancy less than 12 months,
- . Participation in a concurrent clinical study without prior approval from EPD Solutions.
- . Any contra-indication to use KODEX-EPD System per User Manual.
- . Unrecovered/unresolved adverse events from any previous invasive procedure
Trial locations and contacts
22 sites in 8 countries.
22 sites in 8 countries
United States6 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Northwestern Memorial Hospital
Chicago, Illinois, 60611
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
NYU Langone Health
New York, New York, 10016
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Dignity Health Research Institute
Sacramento, California, 95819
Germany5 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen
Bad Oeynhausen, 32545
HELIOS Klinikum Erfurt
Erfurt, 99089
Klinikum Fürth
Fürth, 190766
Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg)
Hamburg, 20246
Kardiologische Gemeinschaftspraxis am Park Sanssouci
Potsdam, 14471
Netherlands3 sites
Catharina Ziekenhuis
Eindhoven
Maastricht UMC
Maastricht, 6229
Sint Anthonius ziekenhuis
Utrecht
Israel2 sites
Hadassah University Medical centrum
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Italy2 sites
Clinica Montevergine
Mercogliano
Monzino Cardiologic Centre, University of Milan.
Milan
United Kingdom1 site
Glenfield Hospital-University of Leicester
Leicester
About this study
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).
Read the 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
- Being tested
- Ablation
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationDevice
Ablation therapy for cardiac arrhythmias
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: Index procedure
Secondary outcomes (2)
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.
Measured: 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.
Measured: Index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start30 Nov 2018
- Primary completion30 Mar 2023
- Study completion30 Mar 2023
Why it stopped: Philips decided to wind down the EPD Solutions business
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 566 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- EPD Solutions, A Philips Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anish Amin, MD, Principal investigator, OhioHealth Riverside Methodist HospitalYitschak Biton, MD, Principal investigator, Hadassah Medical OrganizationMin Tang, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481413
- Sponsor's protocol ID
- CLN-KODEX-0007
- Acronym
- PSOT-PMCF
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2018
- Last updated
- 8 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT03481413
- Acronym / sponsor ID
- PSOT-PMCF / CLN-KODEX-0007
- Conditions
- Arrythmia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Philips decided to wind down the EPD Solutions business
- Enrolment
- 566 participants (actual)
- Lead sponsor
- EPD Solutions, A Philips CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Mar 2023 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- . Subjects who are eligible for an ablation procedure based on local guidelines,
- . Subjects must be 18 years of age or above and at a legal age to give informed consent specific to state and national laws
- . Subjects must be able and willing to comply with all follow-up requirements
Key exclusion criteria (5 listed)
- . Women who are pregnant (as evidenced by pregnancy test if pre-menopausal; method of assessment upon the discretion of the investigator),
- . Life expectancy less than 12 months,
- . Participation in a concurrent clinical study without prior approval from EPD Solutions.
- . Any contra-indication to use KODEX-EPD System per User Manual.
- . Unrecovered/unresolved adverse events from any previous invasive procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AblationAblation therapy for cardiac arrhythmias | Device | – |
Primary outcome
Acute safety event rate when using the KODEX - EPD System
Time frame: 7 days
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
The success rate of the index ablation procedure.
Time frame: Index procedure
A procedure is defined as successful if the following conditions are met: 1. KODEX - EPD System was the only mapping system used in the index ablation procedure. 2. The primary arrhythmia was terminated and validated by operators' standard clinical practice (e.g., pacing).
2 secondary outcomes
12-month safety event rate when the KODEX - EPD System was used in the index ablation procedure and any additional unplanned follow-up procedures.
Time frame: 12 months
Develop PSOT for cardiac arrhythmia patients.
Time frame: Index procedure
Results and safety
The study was stopped early (reason given: Philips decided to wind down the EPD Solutions business). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Arrythmia
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anish Amin, MD principal investigator
OhioHealth Riverside Methodist Hospital
Yitschak Biton, MD principal investigator
Hadassah Medical Organization
Min Tang, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
22 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arrythmia, run by EPD Solutions, A Philips Company at 22 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States, Germany, Netherlands, Belgium, Israel and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Philips decided to wind down the EPD Solutions business). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute safety event rate when using the KODEX - EPD System (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.