Inappropriate Sinus Tachycardia Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AtriCure Commercially Available Devices.
- Who it may be relevant to
- Registry conditions: Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Italy, Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
Overview
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.
Interventions
- Device AtriCure Commercially Available Devices
Epicardial and endocardial hybrid ablation procedure used to treat the IST or POTS using AtriCure commercially available devices.
Primary outcome measures
- AtriCure commercially available devices used to treat IST or POTS [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 9 centers
- Stanford University — Palo Alto
- Sequoia Hospital — Redwood City
- University of Florida — Gainesville
- Sarasota Memorial Hospital — Sarasota
- Kansas City Cardiac Arrhythmia Research — Kansas City
- MedStar Health Research Institute — Hyattsville
- The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati
- Texas Cardiac Arrhythmia Research Foundation — Austin
- … and 1 more center
Belgium · 1 center
- Universitair Ziekenhuis Brussels — Brussels
Italy · 1 center
- IRCCS Ospedale San Raffaele — San Raffaele
Poland · 1 center
- Central Clinic Hospital — Warsaw
Identifiers
NCT: NCT05107635 · RP-2021-IST