Phase
Condition
Heart Defect
Dysrhythmia
Heart Disease
Treatment
AtriCure ISOLATOR Synergy Surgical Ablation System
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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., ratecontrol drugs such as beta-blockers/calcium channel blockers, ivabradine), and/orAADs
Subject is willing and able to provide written informed consent
Exclusion
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-termbronchodilators use, severe asthma or carcinoid syndrome
Subjects who have had a previous catheter ablation in the right atrium for IST orother 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 adrug, 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 orcaretaker as a legal representative) and;
Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results
Study Design
Connect with a study center
UZ Brussels
Brussels,
BelgiumSite Not Available
UZ Brussels
Brussels 2800866,
BelgiumSite Not Available
San Raffaele Hospital
Milan,
ItalySite Not Available
San Raffaele Hospital
Milan 3173435,
ItalySite Not Available
Amsterdam University Medical Center
Amsterdam,
NetherlandsSite Not Available
Amsterdam University Medical Center
Amsterdam 2759794,
NetherlandsSite Not Available
Maastricht University Medical Center
Maastricht,
NetherlandsSite Not Available
Maastricht University Medical Center
Maastricht 2751283,
NetherlandsSite Not Available
Central Clinic Hospital
Warsaw,
PolandSite Not Available
Central Clinic Hospital
Warsaw 756135,
PolandSite Not Available
Northern General Hospital
Sheffield, S5 7AU
United KingdomSite Not Available
Northern General Hospital
Sheffield 2638077, S5 7AU
United KingdomSite Not Available
St. Bernard
Jonesboro 4116834, Arkansas 4099753 72401
United StatesSite Not Available
Loma Linda University Health
Loma Linda, California 92354
United StatesSite Not Available
Sequoia Hospital
Redwood City, California 94062
United StatesActive - Recruiting
Stanford University
Redwood City, California 94063
United StatesSite Not Available
Loma Linda University Health
Loma Linda 5367696, California 5332921 92354
United StatesSite Not Available
Sequoia Hospital
Redwood City 5386834, California 5332921 94062
United StatesSite Not Available
Stanford University
Redwood City 5386834, California 5332921 94063
United StatesSite Not Available
Saint Vincent's Medical Center
Bridgeport, Connecticut 06606
United StatesSite Not Available
Saint Vincent's Medical Center
Bridgeport 5282804, Connecticut 4831725 06606
United StatesSite Not Available
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Medstar Washington Hospital Center
Washington D.C. 4140963, District of Columbia 4138106 20010
United StatesSite Not Available
University of Florida
Gainesville, Florida 32610
United StatesSite Not Available
Baptist Health
Miami, Florida 33143
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesSite Not Available
St. Joseph's Hospital / Baycare Health System
Tampa, Florida 33607
United StatesSite Not Available
University of Florida
Gainesville 4156404, Florida 4155751 32610
United StatesSite Not Available
Baptist Health
Miami 4164138, Florida 4155751 33143
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
St. Joseph's Hospital / Baycare Health System
Tampa 4174757, Florida 4155751 33607
United StatesSite Not Available
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesSite Not Available
Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
United StatesSite Not Available
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United StatesSite Not Available
Saint Alphonsus Regional Medical Center
Boise 5586437, Idaho 5596512 83706
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research LLC
Overland Park 4276873, Kansas 4273857 66211
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Wake Forest University Health Sciences
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available
The Christ Hospital
Cincinnati, Ohio 45219
United StatesSite Not Available
TriHealth, Inc.
Cincinnati, Ohio 45202
United StatesActive - Recruiting
The Christ Hospital
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
TriHealth, Inc.
Cincinnati 4508722, Ohio 5165418 45202
United StatesSite Not Available
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United StatesSite Not Available
Texas Cardiac Arrhythmia Research Foundation
Austin 4671654, Texas 4736286 78705
United StatesSite Not Available
Intermountain Healthcare
Salt Lake City, Utah 84111
United StatesSite Not Available
Intermountain Healthcare
Salt Lake City 5780993, Utah 5549030 84111
United StatesSite Not Available
Virginia Commonwealth University
Richmond, Virginia 23219
United StatesSite Not Available
Virginia Commonwealth University
Richmond 4781708, Virginia 6254928 23219
United StatesSite Not Available
Swedish Medical Center
Seattle, Washington 98122
United StatesSite Not Available
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
United StatesSite Not Available

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