Inappropriate Sinus Tachycardia
Conditions
Brief summary
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.
Interventions
DEVICEAtriCure ISOLATOR Synergy Surgical Ablation System
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Sponsors
AtriCure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness Endpoint | 12-months Post Procedure | 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. |
| Primary Safety Endpoint | 30-days Post Procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6-Minute Walk Test | 24-months Post Procedure | Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure |
| Borg dyspnea score | 24-months Post Procedure | 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. |
| Self-Rating Anxiety Scale | 24-months Post Procedure | Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS) |
| IST symptom reduction | 24-months Post Procedure | IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure |
| QoL - SF-12 | 24-months Post Procedure | 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 |
| Mean heart rate | 24-months Post Procedure | Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring |
| Reduction in mean heart rate in the absence of rate control drugs | 24-months Post Procedure | 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 |
| Reduction in mean heart rate regardless of rate control drugs | 24-months Post Procedure | 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 |
| Device or procedure related Serious Adverse Events | 12-months Post Procedure | Device or procedure related Serious Adverse Events (SAEs) through 12-months |
| Improved heart rate variability - 7-day monitor | 12-months Post Procedure | Improved heart rate variability for subjects using 7-day continuous monitoring |
| Improved heart rate variability - Implantable loop recorder | 12-months Post Procedure | Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs) |
| Health Economics | 24-months Post Procedure | Health Economics: ER visits and readmissions |
Countries
Belgium, Italy, Netherlands, Poland, United Kingdom, United States
Contacts
PRINCIPAL_INVESTIGATORDhanunjaya Lakkireddy, MD
Kansas City Heart Rhythm Institute
PRINCIPAL_INVESTIGATORMark La Meir, MD
Universitair Ziekenhuis Brussel
PRINCIPAL_INVESTIGATORCarlo de Asmundis, MD
Universitair Ziekenhuis Brussel
PRINCIPAL_INVESTIGATORThomas Beaver, MD
University of Florida
Outcome results
None listed