Inappropriate Sinus Tachycardia Registry

Recruiting

• Conditions: Inappropriate Sinus Tachycardia; Postural Tachycardia Syndrome

• Registration Number: NCT05107635
• Lead Sponsor: AtriCure, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-04
• Study Start: 2022-03-01
• Status Verified: 2024-07
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AtriCure commercially available devices used to treat IST or POTS	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.

Trial Locations

Locations (10)

Stanford University; 🇺🇸 Palo Alto, California, United States

Sequoia Hospital; 🇺🇸 Redwood City, California, United States

MedStar Health Research Institute; 🇺🇸 Hyattsville, Maryland, United States

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

University of Florida; 🇺🇸 Gainesville, Florida, United States

Sarasota Memorial Hospital; 🇺🇸 Sarasota, Florida, United States

Kansas City Cardiac Arrhythmia Research; 🇺🇸 Kansas City, Kansas, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States

Universitair Ziekenhuis Brussels; 🇧🇪 Brussels, Belgium