A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment

AtriCure, Inc.10 sites in 2 countries500 target enrollmentMarch 1, 2022

ConditionsInappropriate Sinus Tachycardia Postural Tachycardia Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Inappropriate Sinus Tachycardia
Sponsor: AtriCure, Inc.
Enrollment: 500
Locations: 10
Primary Endpoint: AtriCure commercially available devices used to treat IST or POTS
Status: Recruiting
Last Updated: 6 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2022

End Date

January 1, 2027

Last Updated

6 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

AtriCure, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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

Exclusion Criteria

•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

Outcomes

Primary Outcomes

AtriCure commercially available devices used to treat IST or POTS

Time Frame: 12 months

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.