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NCT Number: NCT05107635

Inappropriate Sinus Tachycardia Registry

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.

Recruiting

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Key information

Conditions

Inappropriate Sinus Tachycardia Autonomic Nervous System Diseases Nervous System Diseases Orthostatic Intolerance Postural Orthostatic Tachycardia Syndrome Postural Tachycardia Syndrome Primary Dysautonomias

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussels, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AtriCure Commercially Available Devices

Device

Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Registry Specialist

CONTACT

[email protected]

866-349-2342

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Nov 4, 2021
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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