History of Changes for Study: NCT03481413

Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study (PSOT-PMCF)

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	March 27, 2018	None (earliest Version on record)
2	May 7, 2018	Study Status
3	May 5, 2022	Recruitment Status, Study Status, Eligibility, Study Identification, Outcome Measures, Study Design, Study Description, Oversight, IPDSharing and Contacts/Locations
4	May 20, 2022	Contacts/Locations, Outcome Measures, Study Identification, Study Description and Study Status
5	June 6, 2023	Recruitment Status, Study Status, Contacts/Locations and Study Design

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	CLN-KODEX-0007
Brief Title:	Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study (PSOT-PMCF)
Official Title:	Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Secondary IDs:

Study Status


Record Verification:	May 2022
Overall Status:	Recruiting
Study Start:	November 30, 2018
Primary Completion:	October 2023 [Anticipated]
Study Completion:	October 2024 [Anticipated]

First Submitted:	March 5, 2018
First Submitted that Met QC Criteria:	March 27, 2018
First Posted:	March 29, 2018 [Actual]

Last Update Submitted that Met QC Criteria:	May 20, 2022
Last Update Posted:	May 26, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	EPD Solutions, A Philips Company
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	Yes
Unapproved/Uncleared Device:
Pediatric Postmarket Surveillance:
Data Monitoring:

Study Description

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


Conditions:	Arrythmia
Keywords:

Study Design


Study Type:	Observational [Patient Registry]
Observational Study Model:	Cohort
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	900 [Anticipated]
Number of Groups/Cohorts	0
Target Follow-Up Duration:	12 Months

Groups and Interventions


Intervention Details:
	Device: Ablation Ablation therapy for cardiac arrhythmias

Outcome Measures


Primary Outcome Measures:
1.	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
2.	The success rate of the index ablation procedure. [ Time Frame: Index 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).
Secondary Outcome Measures:
1.	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 ] 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.
2.	Develop PSOT for cardiac arrhythmia patients. [ Time Frame: Index procedure ] 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.

Eligibility


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.
Sampling Method:	Probability Sample
Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: . 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 Exclusion Criteria . 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

Contacts/Locations


Central Contact Person:	Anneleen Viville Telephone: +32479983495 Email: Anneleen.Viville@philips.com
Study Officials:	Anish Amin, MD Principal Investigator OhioHealth Riverside Methodist Hospital
	Yitschak Biton, MD Principal Investigator Hadassah Medical Organization
	Min Tang, MD Principal Investigator Fuwai Hospital
Locations:	United States, California
	Dignity Health Research Institute [Terminated] Sacramento, California, United States, 95819
	United States, Illinois
	Northwestern Memorial Hospital [Not yet recruiting] Chicago, Illinois, United States, 60611 Contact:Contact: Anna Huskin Contact:Principal Investigator: Bradley Knight, MD
	United States, Maryland
	Johns Hopkins University [Not yet recruiting] Baltimore, Maryland, United States, 21287 Contact:Contact: Kathleen Avara Contact:Principal Investigator: Ronald Berger, MD
	United States, New York
	Montefiore Medical Center [Withdrawn] Bronx, New York, United States, 10467
	NYU Langone Health [Recruiting] New York, New York, United States, 10016 Contact:Contact: April Jacob 212-263-7704 April.Jacob@nyulangone.org Contact:Principal Investigator: Larry Chinitz, MD
	United States, Ohio
	OhioHealth Riverside Methodist Hospital [Not yet recruiting] Columbus, Ohio, United States, 43214 Contact:Contact: Christina Belcher Contact:Principal Investigator: Anisch Amin, MD
	United States, Pennsylvania
	Hospital of the University of Pennsylvania [Recruiting] Philadelphia, Pennsylvania, United States, 19104 Contact:Contact: Mary Gnap Contact:Principal Investigator: Matthew Hyman
	Belgium
	Onze Lieve Vrouw Ziekenhuis Aalst [Recruiting] Aalst, Belgium Contact:Contact: Hilde Delacroix Contact:Principal Investigator: Tom De Potter
	AZ Sint Jan [Recruiting] Brugge, Belgium Contact:Contact: Tineke De Grande Contact:Principal Investigator: Mattias Duytschaever
	Germany
	Herz- und Diabeteszentrum Nordrhein-Westfalen [Not yet recruiting] Bad Oeynhausen, Germany, 32545 Contact:Contact: Bastian Grube Contact:Principal Investigator: Philipp Sommer, MD
	HELIOS Klinikum Erfurt [Not yet recruiting] Erfurt, Germany, 99089 Contact:Contact: Violeta Mattea Contact:Principal Investigator: Anja Schade, MD
	Klinikum Fürth [Not yet recruiting] Fürth, Germany, 190766 Contact:Contact: Dirk Bastian Contact:Principal Investigator: Dirk Bastian, MD
	Universitätsklinikum Hamburg-Eppendorf (UKE Hamburg) [Not yet recruiting] Hamburg, Germany, 20246 Contact:Contact: Anke Heiermann Contact:Principal Investigator: Andreas Rillig, MD
	Kardiologische Gemeinschaftspraxis am Park Sanssouci [Not yet recruiting] Potsdam, Germany, 14471 Contact:Contact: Julia Frey Contact:Principal Investigator: Gerhard Janssen, MD
	Israel
	Hadassah University Medical centrum [Recruiting] Jerusalem, Israel Contact:Contact: Galina Levin Contact:Principal Investigator: Yitschak Biton
	Shaare Zedek Medical Center [Recruiting] Jerusalem, Israel Contact:Contact: Lea Dotan Contact:Principal Investigator: Michael Glikson
	Italy
	Clinica Montevergine [Recruiting] Mercogliano, Italy Contact:Contact: Carmen Del Guidice Contact:Principal Investigator: Francesco Solimene
	Monzino Cardiologic Centre, University of Milan. [Recruiting] Milan, Italy Contact:Contact: Rita Sicuso Contact:Principal Investigator: Claudio Tondo
	Netherlands
	Catharina Ziekenhuis [Recruiting] Eindhoven, Netherlands Contact:Contact: Linda van Leur Contact:Principal Investigator: Lucas Dekker
	Maastricht UMC [Not yet recruiting] Maastricht, Netherlands, 6229 Contact:Contact: Marisevi Chaldoupi Contact:Principal Investigator: Marisevi Chaldoupi, MD
	Sint Anthonius ziekenhuis [Recruiting] Utrecht, Netherlands Contact:Contact: Rosana Nakamura Contact:Principal Investigator: Lucas Boersma
	Switzerland
	Fondazione Cardiocentro Ticino [Recruiting] Lugano, Switzerland Contact:Principal Investigator: Angelo Auricchio
	United Kingdom
	Glenfield Hospital-University of Leicester [Recruiting] Leicester, United Kingdom Contact:Contact: Michelle Newton Contact:Principal Investigator: Andre Ng

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: