Clinical trial NCT03858361: Patient Specific Optimized Therapy (PSOT)
Official title: Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Data Collection
Lead sponsor: EPD Solutions, A Philips Company
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 566
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Arrhythmia patients with Atrial Flutter indicated for EP procedures.

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.

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.

Primary outcomes:
measure: Arrhythmia recurrence The number of Arrhythmia recurrence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Florida City
country: United States
facility: Baptist Health South Florida
state: Florida
Study officials:
References: