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Inappropriate Sinus Tachycardia Registry

NCT05107635 — Recruiting, 500 participants, AtriCure, Inc.
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A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment

RegistryNCT05107635
StatusRecruiting
Study typeObservational
Enrollment500 (Estimated)
SponsorAtriCure, Inc. (Industry)
ConditionsInappropriate Sinus Tachycardia, Postural Tachycardia Syndrome
InterventionsAtriCure Commercially Available Devices (Device)
Datesstart 2022-03-01, primary completion 2030-01-01 (estimated), completion 2030-01-01 (estimated), first posted 2021-11-04, last updated 2026-10-07
Locations15 sites in United States, Belgium, Italy, Poland

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-Summary

The primary objective of this registry is to capture real-world safety and performance data on AtriCure devices used to ablate cardiac tissue when treating Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). This is a retrospective and prospective, multicenter, US/OUS, observational data registry.

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+Arms and interventions

  • AtriCure Commercially Available Devices (Device): Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.

+Outcome measures

Primary outcomes

  • AtriCure commercially available devices used to treat IST or POTS [5 years]: The IST Registry will attempt to enroll all eligible patients at registry sites who have already had or are scheduled to have a procedure to treat IST/POTS that includes the use of at least one commercially available AtriCure cardiac ablation devices.

+Eligibility

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

1. Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
2. Subject is willing to provide written informed consent (defined as legally effective, documented confirmation of a subject's voluntary agreement to participate in this Registry) or authorization per institution and geographical requirements

Exclusion Criteria:

1. Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
2. Subject with exclusion criteria required by FDA or local governance

+Locations (15)

FacilityCityCountryStatus
Loma Linda University HealthLoma Linda, CaliforniaUnited StatesRecruiting
Stanford UniversityPalo Alto, CaliforniaUnited StatesRecruiting
Sequoia HospitalRedwood City, CaliforniaUnited StatesRecruiting
University of FloridaGainesville, FloridaUnited StatesRecruiting
HCA Osceola Regional Medical CenterKissimmee, FloridaUnited StatesRecruiting
Sarasota Memorial HospitalSarasota, FloridaUnited StatesRecruiting
Kansas City Cardiac Arrhythmia ResearchKansas City, KansasUnited StatesRecruiting
MedStar Health Research InstituteHyattsville, MarylandUnited StatesRecruiting
The Carl & Edyth Lindner Center for Research & Education at The Christ HospitalCincinnati, OhioUnited StatesRecruiting
Texas Cardiac Arrhythmia Research FoundationAustin, TexasUnited StatesRecruiting
Intermountain Medical CenterMurray, UtahUnited StatesRecruiting
Swedish Health ServicesSeattle, WashingtonUnited StatesRecruiting
Universitair Ziekenhuis BrusselsBrusselsBelgiumRecruiting
IRCCS Ospedale San RaffaeleSan RaffaeleItalyRecruiting
Central Clinic HospitalWarsawPolandRecruiting

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