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Inappropriate Sinus Tachycardia Registry

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ClinicalTrials.gov Identifier: NCT05107635
Recruitment Status : Recruiting
First Posted : November 4, 2021
Last Update Posted : February 6, 2023
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Inappropriate Sinus Tachycardia Postural Tachycardia Syndrome Device: AtriCure Isolator® Synergy™ Surgical Ablation System

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 12 Months
Official Title: A Multicenter Patient Registry for Outcomes of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome Treatment
Actual Study Start Date : March 1, 2022
Estimated Primary Completion Date : January 2027
Estimated Study Completion Date : January 2027
Groups and Cohorts
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  1. Outcome of AtriCure Isolator® Synergy™ Clamp System used to treat IST or POTS [ Time Frame: 12 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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 and must meet all eligibility criteria in order for their treatment and results to be considered for this Registry.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05107635


Locations
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Belgium
Universitair Ziekenhuis Brussels Recruiting
Brussels, Belgium
Contact: Brian Roelandt    02/476 36 56    Brian.Roelandt@uzbrussel.be   
Principal Investigator: Carlo de Asmundis, MD PhD         
Sponsors and Collaborators
AtriCure, Inc.
More Information
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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT05107635    
Other Study ID Numbers: RP-2021-IST
First Posted: November 4, 2021    Key Record Dates
Last Update Posted: February 6, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by AtriCure, Inc.:
Inappropriate Sinus Tachycardia
Postural Tachycardia Syndrome;
Sinus Node Sparing Hybrid Procedure
Additional relevant MeSH terms:
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Postural Orthostatic Tachycardia Syndrome
Tachycardia
Tachycardia, Sinus
Syndrome
Disease
Pathologic Processes
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Orthostatic Intolerance
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Tachycardia, Supraventricular