NCT05107635

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
2 countries

10 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Mar 2022Jan 2027

First Submitted

Initial submission to the registry

October 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

October 20, 2025

Status Verified

September 1, 2025

Enrollment Period

4.8 years

First QC Date

October 28, 2021

Last Update Submit

October 16, 2025

Conditions

Keywords

Inappropriate Sinus TachycardiaPostural Tachycardia Syndrome;Sinus Node Sparing Hybrid Procedure

Outcome Measures

Primary Outcomes (1)

  • AtriCure commercially available devices used to treat IST or POTS

    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.

    12 months

Interventions

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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The IST registry eligibility is open to sites and physicians performing the described treatments for patients diagnosed with IST and POTS. Subjects must have been scheduled to undergo or have undergone the described treatments for IST or POTS by their physicians. Registry participating sites will enroll patients that meet all inclusion criteria and no exclusion criteria without preselection or bias.

You may qualify if:

  • 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

You may not qualify if:

  • Subject is enrolled in a concurrent study that may impact treatment outcome of IST or POTS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Stanford University

Palo Alto, California, 94305, United States

RECRUITING

Sequoia Hospital

Redwood City, California, 94062, United States

RECRUITING

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

RECRUITING

Kansas City Cardiac Arrhythmia Research

Kansas City, Kansas, 64132, United States

RECRUITING

MedStar Health Research Institute

Hyattsville, Maryland, 20782, United States

RECRUITING

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

Cincinnati, Ohio, 45219, United States

RECRUITING

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

RECRUITING

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Universitair Ziekenhuis Brussels

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System Diseases

Central Study Contacts

Registry Specialist

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 4, 2021

Study Start

March 1, 2022

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

October 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations