Status:
TERMINATED
Patient Specific Optimized Therapy (PSOT)
Lead Sponsor:
EPD Solutions, A Philips Company
Conditions:
Data Collection
Eligibility:
All Genders
18+ years
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) t...
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 col...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2023
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT03858361
Start Date
September 13 2019
End Date
March 28 2023
Last Update
June 8 2023
Active Locations (1)
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1
Baptist Health South Florida
Florida City, Florida, United States, 33143