AtriCure ISOLATOR Synergy Surgical Ablation System
AtriCure ISOLATOR Synergy Surgical Ablation System: Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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
Trial sites (27)
Facility
City
Region
Status
St. Bernard
Jonesboro
Arkansas
Loma Linda University Health
Loma Linda
California
Sequoia Hospital
Redwood City
California
Stanford University
Redwood City
California
Saint Vincent's Medical Center
Bridgeport
Connecticut
Medstar Washington Hospital Center
Washington D.C.
District of Columbia
University of Florida
Gainesville
Florida
Baptist Health
Miami
Florida
Sarasota Memorial Hospital
Sarasota
Florida
St. Joseph's Hospital / Baycare Health System
Tampa
Florida
Memorial Health University Medical Center
Savannah
Georgia
Saint Alphonsus Regional Medical Center
Boise
Idaho
Kansas City Cardiac Arrhythmia Research LLC
Overland Park
Kansas
Mayo Clinic
Rochester
Minnesota
Wake Forest University Health Sciences
Winston-Salem
North Carolina
TriHealth, Inc.
Cincinnati
Ohio
The Christ Hospital
Cincinnati
Ohio
Texas Cardiac Arrhythmia Research Foundation
Austin
Texas
Intermountain Healthcare
Salt Lake City
Utah
Virginia Commonwealth University
Richmond
Virginia
Swedish Medical Center
Seattle
Washington
UZ Brussels
Brussels
Belgium
San Raffaele Hospital
Milan
Italy
Amsterdam University Medical Center
Amsterdam
Netherlands
Maastricht University Medical Center
Maastricht
Netherlands
Central Clinic Hospital
Warsaw
Poland
Northern General Hospital
Sheffield
United Kingdom
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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