Inappropriate Sinus Tachycardia Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorAtriCure, Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
Subject is scheduled to undergo or has undergone a procedure to treat IST or POTS using one or more AtriCure devices.
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
Disqualifiers
Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.
Subject with exclusion criteria required by FDA or local governance
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
AtriCure Commercially Available Devices
DeviceEpicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
AtriCure commercially available devices used to treat IST or POTS
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.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov