Patient Specific Optimized Therapy (PSOT) (PSOT)

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

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.

Study Overview

• Status: Terminated
• Conditions: Data Collection
• Intervention / Treatment: Device: Atrial Flutter Ablation

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.

• Study Type: Observational
• Enrollment (Actual): 566

Contacts and Locations

Study Locations

• United States
  • Florida
    • Florida City, Florida, United States, 33143
      • Baptist Health South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Arrhythmia patients with Atrial Flutter indicated for EP procedures.

Description

Inclusion Criteria:

• Subject is at least 18 years of age.
• Subject signed a written Informed Consent form to participate in the study, prior to any study related procedures.
• Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.
• A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
• Subject is deemed amenable to therapeutic ablation for atrial flutter.

Exclusion Criteria:

• Any planned surgical or endovascular intervention within 30 days before or after the index procedure.
• Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
• Patient had experienced previous stroke (TIA or CVA).
• Thrombi detected in the heart.
• Known marked valvar insufficiency.
• Life expectancy less than 12 months.
• Known severe renal insufficiency.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia recurrence The number of Arrhythmia recurrence	The number of arrhythmia recurrence	3 months

Collaborators and Investigators

• Sponsor: EPD Solutions, A Philips Company

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Actual): March 28, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 26, 2019
• First Posted (Actual): February 28, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2023
• Last Update Submitted That Met QC Criteria: June 6, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CLN-KODEX-0011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No