Recruiting

Observational Study

Sponsor:

AtriCure, Inc.

Code:

NCT05107635

Conditions

Inappropriate Sinus Tachycardia

Postural Tachycardia Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

AtriCure Commercially Available Devices

Study Details

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.

Conditions

Inappropriate Sinus Tachycardia

Postural Tachycardia Syndrome

Study ID

NCT05107635

Start date

Mar 1, 2022

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

AtriCure Commercially Available Devices

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

Primary outcome measure

  • AtriCure commercially available devices used to treat IST or POTS [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Locations

Loma Linda University Health

Recruiting

Loma Linda, California, United States, 92354

Contacts

Kisha-Nicole Hefflin

909-651-9865khefflin@llu.edu

Principal Investigator:

Jalaj Garg, MD

Stanford University

Recruiting

Palo Alto, California, United States, 94305

Contacts

Principal Investigator:

Anson Lee

Sequoia Hospital

Recruiting

Redwood City, California, United States, 94062

Contacts

Principal Investigator:

Chad Brodt

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Principal Investigator:

Thomas Beaver

HCA Osceola Regional Medical Center

Recruiting

Kissimmee, Florida, United States, 34741

Contacts

Principal Investigator:

Steven Hoff, MD

Sarasota Memorial Hospital

Recruiting

Sarasota, Florida, United States, 34239

Contacts

Principal Investigator:

Paul Vesco

Kansas City Cardiac Arrhythmia Research

Recruiting

Kansas City, Kansas, United States, 64132

Contacts

Principal Investigator:

Dhanunjaya Lakkireddy

MedStar Health Research Institute

Recruiting

Hyattsville, Maryland, United States, 20782

Contacts

The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Principal Investigator:

Michael Smith

Texas Cardiac Arrhythmia Research Foundation

Recruiting

Austin, Texas, United States, 78705

Contacts

Principal Investigator:

Andrea Natale

Intermountain Medical Center

Recruiting

Murray, Utah, United States, 84107

Contacts

Principal Investigator:

John Doty

Swedish Health Services

Recruiting

Seattle, Washington, United States, 98122

Contacts

Principal Investigator:

Eric Lehr, MD

More Information

Sponsor

AtriCure, Inc.

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Keywords

  • Inappropriate Sinus Tachycardia
  • Postural Tachycardia Syndrome;
  • Sinus Node Sparing Hybrid Procedure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AtriCure, Inc. on 2026-08-27.