Table 3.

Inclusion and exclusion criteria

Inclusion criteria

1.Age ≥18 y and ≤75 y at time of enrollment consent 2. Subject has a diagnosis of IST: a. Documentation of mean heart rate >90 beats/min with 7-d monitor at baseline and b. Documentation of a resting heart rate of >100 beats/min and c. Documentation of presence of IST for at least 6 mo d. Documentation of absence of other tachycardias e. Documentation of absence of secondary causes such as hormonal issues or systemic illness that might contribute to increased heart rate 3.Documentation of refractoriness (intolerance or failure) of a drug (eg, 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 cardiothoracic surgery 5.LVEF <50% 6.BMI ≥35 kg/m2 7.Presence of supraventricular or ventricular tachycardia 8.Presence of 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 bronchodilator 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 mo 13.Pregnant or planning to become pregnant during study 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 study that may interfere with study results 18.Not competent to legally represent him or herself (eg, requires a guardian or caretaker as a legal representative) 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

AAD = antiarrhythmic drug; BMI = body mass index; COPD = chronic obstructive pulmonary disease; ICD = implantable cardioverter-defibrillator; IST = inappropriate sinus tachycardia; LVEF = left ventricular ejection fraction; POTS = postural orthostatic sinus tachycardia.