Clinical trial NCT05107635: Inappropriate Sinus Tachycardia Registry
Official title: A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Inappropriate Sinus Tachycardia
Postural Tachycardia Syndrome
Keywords: Inappropriate Sinus Tachycardia
Postural Tachycardia Syndrome;
Sinus Node Sparing Hybrid Procedure
Lead sponsor: AtriCure, Inc.
Sponsor class: INDUSTRY
First posted: 2021-11-04
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: AtriCure commercially available devices used to treat IST or POTS
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Redwood City
country: United States
facility: Sequoia Hospital
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Memorial Hospital
state: Florida
city: Kansas City
country: United States
facility: Kansas City Cardiac Arrhythmia Research
state: Kansas
city: Hyattsville
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
state: Ohio
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia Research Foundation
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis Brussels
Study officials:
References: