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(352) 733-0111

IST Registry

  • Status
    Accepting Candidates
  • Age
    18 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

Full study title Inappropriate Sinus Tachycardia (IST) Registry
Protocol number OCR42349
ClinicalTrials.gov ID NCT05107635

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

Lead researcher

  • Kun "Kevin" Xiang, MD, PhD
    Cardiologist (Heart Specialist), Clinical Cardiologist - Electrophysiology Specialist
    Kun "Kevin" Xiang

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.