NCT03858361

Patient Specific Optimized Therapy (PSOT)

Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 566 (actual)
• Sponsor: EPD Solutions, A Philips Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Data collection from atrial flutter patients before, during and after undergoing catheter-based electrophysiological (EP) intervention in order to develop a patient specific optimized therapy (PSOT) to improve specific patient's arrhythmia treatment for Atrial Flutter.

Detailed description

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.

Conditions

• Data Collection

Interventions

Type	Name	Description
DEVICE	Atrial Flutter Ablation	Catheter-based electrophysiological (EP) intervention.

Timeline

• Start date: 2019-09-13
• Primary completion: 2023-03-28
• Completion: 2023-03-28
• First posted: 2019-02-28
• Last updated: 2023-06-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study