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NCT05107635 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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