Inappropriate Sinus Tachycardia Registry

Postural Tachycardia Syndrome Clinical Trial

Official title:

A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05107635
• Other study ID #: RP-2021-IST
• Status: Recruiting
• Start date: March 1, 2022
• Est. completion date: January 2027

Study information

• Verified date: February 2023
• Source: AtriCure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary objective of this registry is to capture the real-world data on the outcome of AtriCure Isolator® Synergy™ Surgical Ablation system (or future iterations) when used to ablate cardiac tissue in patients with Inappropriate Sinus Tachycardia (IST) or Postural Tachycardia Syndrome (POTS) using sinus node sparing hybrid ablation procedures. This is an observational, retrospective and prospective, multicenter, open-label patient registry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 2027
• Est. primary completion date: January 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is age>=18 years

2. Subject has been scheduled by physician to undergo or has undergone hybrid sinus node ablation procedure using the AtriCure Isolator® Synergy™ device or future iterations of that device for IST or POTS

3. 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 has not been approved for concurrent enrollment by the global study manager

2. Subject with exclusion criteria required by FDA or local governance

Related Conditions & MeSH terms

• Inappropriate Sinus Tachycardia
• Postural Orthostatic Tachycardia Syndrome
• Postural Tachycardia Syndrome
• Syndrome
• Tachycardia
• Tachycardia, Sinus

Intervention

Device:
• AtriCure Isolator® Synergy™ Surgical Ablation System
A sinoatrial (SA) node sparing, endoscopic epicardial and endocardial hybrid ablation approach used to treat the IST or POTS using the AtriCure Isolator® Synergy™ Surgical Ablation System and Isolator® pen devices as applicable.

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussels	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
AtriCure, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of AtriCure Isolator® Synergy™ Clamp System used to treat IST or POTS	The data associated with the SA node sparing hybrid ablation procedure using the AtriCure Isolator® Synergy™ Clamp system to treat patients diagnosed with IST or POTS will be captured and assessed in this registry study.	12 months