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Hybrid ablation procedure for inappropriate sinus tachycardia

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

Not applicable Interventional AtriCure, Inc. · NCT05280093

This study is testing a new procedure to see if it can help younger people with inappropriate sinus tachycardia who haven't found relief from medications.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment142 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAtriCure, Inc. Industry-sponsored
Locations26 sites (Loma Linda, California and 25 other locations)
Trial IDNCT05280093 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of a hybrid sinus node sparing ablation procedure for patients suffering from inappropriate sinus tachycardia (IST) who are intolerant or refractory to drug treatments. The study aims to provide a systematic clinical approach to a condition that significantly impacts the quality of life of otherwise healthy younger individuals. Participants will undergo the AtriCure ISOLATOR Synergy Surgical Ablation System intervention to assess its efficacy in alleviating symptoms associated with IST.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a confirmed diagnosis of IST who have not responded to or cannot tolerate standard drug therapies.

Not a fit: Patients with existing cardiac devices, significant heart failure, or other specified cardiac conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could offer a new treatment option for patients with drug-resistant inappropriate sinus tachycardia, improving their quality of life.

How similar studies have performed: While there is limited systematic clinical evidence for IST treatments, similar ablation approaches have shown promise in other tachycardia conditions, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Loma Linda, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Inappropriate Sinus Tachycardia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.