HEAL-IST IDE Trial

Recruiting

Trial ID: NCT05280093

Purpose

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.

Official Title

Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

Stanford Investigator(s)

Nitish Badhwar
Nitish Badhwar

Clinical Professor, Medicine - Cardiovascular Medicine

Albert "A.J." Rogers, MD, MBA
Albert "A.J." Rogers, MD, MBA

Instructor, Medicine - Cardiovascular Medicine

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

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

12. Life expectancy < 24 months

13. Pregnant or planning to become pregnant during trial

14. Subjects with substance abuse

15. Subjects with previous weight loss surgery

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

17. 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

18. Not competent to legally represent him or herself (e.g., requires a guardian or
   caretaker as a legal representative) and;

19. 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

Intervention(s):

device: AtriCure ISOLATOR Synergy Surgical Ablation System

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305