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Patient Specific Optimized Therapy (PSOT) (PSOT)

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ClinicalTrials.gov Identifier: NCT03858361
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
EPD Solutions, A Philips Company

Study Description
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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.

Condition or disease Intervention/treatment
Data Collection 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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Patient Specific Optimized Therapy (PSOT) in Atrial Flutter Population Miami Cardiac & Vascular Institute (MCVI) Post Marketing Surveillance (PMS) Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019
Groups and Cohorts
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Intervention Details:
  • Device: Atrial Flutter Ablation
    Catheter-based electrophysiological (EP) intervention.

Outcome Measures
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Primary Outcome Measures :
  1. Arrhythmia recurrence The number of Arrhythmia recurrence [ Time Frame: 3 months ]
    The number of arrhythmia recurrence


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Arrhythmia patients with Atrial Flutter indicated for EP procedures.
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

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Responsible Party: EPD Solutions, A Philips Company
ClinicalTrials.gov Identifier: NCT03858361    
Other Study ID Numbers: CLN-KODEX-0011
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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