Patient Specific Optimized Therapy (PSOT) (PSOT)
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|ClinicalTrials.gov Identifier: NCT03858361|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment|
|Data Collection||Device: Atrial Flutter Ablation|
Prospective, single-center, non-randomized, open label, single arm study. Consented subjects who are scheduled to undergo ablation due to atrial flutter will be enrolled in the study. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 3 months.
KODEX - EPD™ system will be used in all procedures during treatment of cardiac arrhythmias.
Anonymized data will be stored in an EPD database and will be used to train and test predictors for personalized optimized therapy.
Data will be collected on paper and/or electronic forms and saved in the EPD Database.
Advanced data analysis will be used to map patient specific demographics, history, current ailment, intervention to patient outcome. The technology to be utilized will help develop a method to identify the personalized treatment for a given patient (defined by: patient's demographic, history, current ailment and intervention information to achieve optimal outcome).
Data will be anonymized by removing patient protected health information, only initials will be used. The data will be integrated to an EPD data base and will be used to train and test predictors for personalized optimized therapy.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||30 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
- Device: Atrial Flutter Ablation
Catheter-based electrophysiological (EP) intervention.
- Arrhythmia recurrence The number of Arrhythmia recurrence [ Time Frame: 3 months ]The number of arrhythmia recurrence