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(352) 733-0111

HEAL-IST

  • Status
    Accepting Candidates
  • Age
    18 Years - 75 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

Details

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

Eligibility

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

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

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  4. Step
    4

    Participate

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