HEAL-IST IDE Trial

Study Overview
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Brief Summary
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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
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Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

Conditions
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Inappropriate Sinus Tachycardia

Intervention / Treatment
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* Device: AtriCure ISOLATOR Synergy Surgical Ablation System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years and ≤ 75 years at time of enrollment consent Subject has a diagnosis of IST 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 Subject is willing and able to provide written informed consent Exclusion Criteria: Subjects on whom cardiac surgery or single lung ventilation cannot be performed Subjects with indication for or existing ICDs/Pacemakers Presence of channelopathies Previous cardio-thoracic surgery Left Ventricular Ejection Fraction (LVEF) < 50% Body Mass Index (BMI) ≥ 35 Presence of supraventricular or ventricular tachycardia Presence of Postural Orthostatic Sinus Tachycardia (POTS) Presence of congenital heart disease 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 Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders Life expectancy < 24 months Pregnant or planning to become pregnant during trial Subjects with substance abuse Subjects with previous weight loss surgery Subject is unwilling and/or unable to return for scheduled follow-up visits 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 Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hybrid sinus node sparing ablation procedure<br>Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System | Device: AtriCure ISOLATOR Synergy Surgical Ablation System<br>* Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Effectiveness Endpoint | Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of ≤ 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications. | 12-months Post Procedure | 
| Primary Safety Endpoint | Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure | 30-days Post Procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-Minute Walk Test | Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure | 24-months Post Procedure | 
| Borg dyspnea score | Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT. | 24-months Post Procedure | 
| Self-Rating Anxiety Scale | Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS) | 24-months Post Procedure | 
| IST symptom reduction | IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure | 24-months Post Procedure | 
| QoL - SF-12 | Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure | 24-months Post Procedure | 
| Mean heart rate | Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring | 24-months Post Procedure | 
| Reduction in mean heart rate in the absence of rate control drugs | Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs | 24-months Post Procedure | 
| Reduction in mean heart rate regardless of rate control drugs | Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs | 24-months Post Procedure | 
| Device or procedure related Serious Adverse Events | Device or procedure related Serious Adverse Events (SAEs) through 12-months | 12-months Post Procedure | 
| Improved heart rate variability - 7-day monitor | Improved heart rate variability for subjects using 7-day continuous monitoring | 12-months Post Procedure | 
| Improved heart rate variability - Implantable loop recorder | Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs) | 12-months Post Procedure | 
| Health Economics | Health Economics: ER visits and readmissions | 24-months Post Procedure |