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 regi
| Condition(s) | Inappropriate Sinus Tachycardia, Postural Tachycardia Syndrome |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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. |
| Who can participate | 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 |
| Sex | All |
| Lead sponsor | AtriCure, Inc. |
| Locations | Palo Alto, California, United States; Redwood City, California, United States; Gainesville, Florida, United States; Sarasota, Florida, United States; Kansas City, Kansas, United States; Hyattsville, Maryland, United States (+4 more sites) |
| Start date | 2022-03-01 |
| NCT ID | NCT05107635 |
| Official listing | https://clinicaltrials.gov/study/NCT05107635 |