Patient Specific Optimized Therapy (PSOT)

Data Collection Clinical Trial

— PSOT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858361
• Other study ID #: CLN-KODEX-0011
• Status: Terminated
• Start date: September 13, 2019
• Est. completion date: March 28, 2023

Study information

• Verified date: June 2023
• Source: EPD Solutions, A Philips Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 566
• Est. completion date: March 28, 2023
• Est. primary completion date: March 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Data Collection

Intervention

Device:
• Atrial Flutter Ablation
Catheter-based electrophysiological (EP) intervention.

Locations

Country	Name	City	State
United States	Baptist Health South Florida	Florida City	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EPD Solutions, A Philips Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia recurrence The number of Arrhythmia recurrence	The number of arrhythmia recurrence	3 months