Patient Specific Optimized Therapy (PSOT)

NCT ID: NCT03858361

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 566 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-13
• Study Completion Date: 2023-03-28

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Atrial Flutter Ablation

Catheter-based electrophysiological (EP) intervention.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EPD Solutions, A Philips Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Baptist Health South Florida

Florida City, Florida, United States

Countries

United States

Other Identifiers

CLN-KODEX-0011

Identifier Type: -

Identifier Source: org_study_id