Registry for Inappropriate Sinus Tachycardia and Postural Tachycardia Syndrome treatments
A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
This study is collecting information on the safety and effectiveness of AtriCure devices used to treat people with Inappropriate Sinus Tachycardia or Postural Tachycardia Syndrome.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | All |
| Sponsor | AtriCure, Inc. Industry-sponsored |
| Locations | 10 sites (Palo Alto, California and 9 other locations) |
| Trial ID | NCT05107635 on ClinicalTrials.gov |
What this trial studies
This registry aims to collect real-world safety and performance data on AtriCure devices used for ablating cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS). It includes both retrospective and prospective data collection from multiple centers across the US and internationally. Patients who are scheduled for or have undergone treatment with AtriCure devices will be monitored to assess outcomes and safety profiles.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients scheduled to undergo or who have already undergone a procedure for IST or POTS using AtriCure devices.
Not a fit: Patients currently enrolled in other studies that may affect the treatment outcomes for IST or POTS will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of AtriCure devices for treating IST and POTS, potentially improving patient care.
How similar studies have performed: Other studies involving similar observational approaches have shown success in capturing real-world data, making this registry a valuable addition to existing knowledge.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Palo Alto, California and 9 other locations
- Stanford University — Palo Alto, California, United States (Recruiting)
- Sequoia Hospital — Redwood City, California, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
- Sarasota Memorial Hospital — Sarasota, Florida, United States (Recruiting)
- Kansas City Cardiac Arrhythmia Research — Kansas City, Kansas, United States (Recruiting)
- MedStar Health Research Institute — Hyattsville, Maryland, United States (Recruiting)
- The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital — Cincinnati, Ohio, United States (Recruiting)
- Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States (Recruiting)
- Intermountain Medical Center — Murray, Utah, United States (Recruiting)
- Universitair Ziekenhuis Brussels — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Registry Specialist
- Email: IST-Registry@atricure.com
- Phone: 866-349-2342
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.