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).
Brief Title
Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
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.
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Arrythmia
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
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
Inclusion 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03481413
Org Class
Industry
Org Full Name
EPD Solutions, A Philips Company
Org Study Id
CLN-KODEX-0007
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Patient Specific Optimized Therapy Post-Market Clinical Follow-up Study
Primary Outcomes
Outcome Description
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
Outcome Measure
Acute safety event rate when using the KODEX - EPD System
Outcome Time Frame
7 days
Outcome Description
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).
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).
Outcome Measure
The success rate of the index ablation procedure.
Outcome Time Frame
Index procedure
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
12 months
Outcome 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.
Outcome Description
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.
Outcome Time Frame
Index procedure
Outcome Measure
Develop PSOT for cardiac arrhythmia patients.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Both male and female subjects who meet all eligibility criteria and give written informed consent will be enrolled in the study.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637