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  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
  • Healthy Volunteers


Inappropriate Sinus Tachycardia (IST) is a prevalent and debilitating condition in otherwise healthy younger patients, resulting in significant loss of quality of life, lacking effective treatment options or systematic clinical evidence to support a therapy. The primary objective of this clinical trial is to evaluate the safety and effectiveness of a hybrid sinus node sparing ablation procedure for the treatment of symptomatic drug refractory or drug intolerant IST.


Full study title Hybrid Epicardial and Endocardial Sinus-Node SpAring AbLation Therapy for Inappropriate Sinus Tachycardia
Protocol number OCR42214 ID NCT05280093
Phase N/A


Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 75 years at time of enrollment consent

  2. Subject has a diagnosis of IST

  3. Documentation of refractoriness (intolerance or failure) of a drug (e.g., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs

  4. Subject is willing and able to provide written informed consent

Exclusion Criteria:

  1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed

  2. Subjects with indication for or existing ICDs/Pacemakers

  3. Presence of channelopathies

  4. Previous cardio-thoracic surgery

  5. Left Ventricular Ejection Fraction (LVEF) < 50%

  6. Body Mass Index (BMI) ≥ 35

  7. Presence of supraventricular or ventricular tachycardia

  8. Presence of Postural Orthostatic Sinus Tachycardia (POTS)

  9. Presence of congenital heart disease

  10. History suggestive of secondary cause of tachycardia such as pheochromocytoma, anemia,

thyrotoxicosis, chronic fever of unknown origin, COPD, long-term bronchodilators use,

severe asthma or carcinoid syndrome

  1. Subjects who have had a previous catheter ablation in the right atrium for IST or

other disorders

  1. Life expectancy < 24 months

  2. Pregnant or planning to become pregnant during trial

  3. Subjects with substance abuse

  4. Subjects with previous weight loss surgery

  5. Subject is unwilling and/or unable to return for scheduled follow-up visits

  6. Current participation in another clinical investigation of a medical device or a drug,

or recent participation in such a trial that may interfere with trial results

  1. Not competent to legally represent him or herself (e.g., requires a guardian or

caretaker as a legal representative) and;

  1. Presence of other anatomic or comorbid conditions, or other medical, social, or

psychological conditions that, in the investigator's opinion, could limit the

subject's ability to participate in the clinical investigation or to comply with

follow-up requirements, or impact the scientific soundness of the clinical

investigation results

Lead researcher

Participate in a study

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  1. Step

    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

    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

    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


    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.