Phase
Condition
Heart Defect
Cardiac Disease
Fast Heart Rate (Tachycardia)
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,
BelgiumActive - Recruiting
San Raffaele Hospital
Milan,
ItalyActive - Recruiting
Amsterdam University Medical Center
Amsterdam,
NetherlandsActive - Recruiting
Maastricht University Medical Center
Maastricht,
NetherlandsActive - Recruiting
Central Clinic Hospital
Warsaw,
PolandActive - Recruiting
Northern General Hospital
Sheffield, S5 7AU
United KingdomActive - Recruiting
Loma Linda University Health
Loma Linda, California 92354
United StatesActive - Recruiting
Sequoia Hospital
Redwood City, California 94062
United StatesActive - Recruiting
Stanford University
Redwood City, California 94063
United StatesActive - Recruiting
Saint Vincent's Medical Center
Bridgeport, Connecticut 06606
United StatesActive - Recruiting
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesActive - Recruiting
University of Florida
Gainesville, Florida 32610
United StatesActive - Recruiting
Baptist Health
Miami, Florida 33143
United StatesSite Not Available
Sarasota Memorial Hospital
Sarasota, Florida 34239
United StatesActive - Recruiting
St. Joseph's Hospital / Baycare Health System
Tampa, Florida 33607
United StatesActive - Recruiting
Memorial Health University Medical Center
Savannah, Georgia 31404
United StatesActive - Recruiting
Saint Alphonsus Regional Medical Center
Boise, Idaho 83706
United StatesSite Not Available
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas 66211
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United StatesActive - Recruiting
The Christ Hospital
Cincinnati, Ohio 45219
United StatesActive - Recruiting
TriHealth, Inc.
Cincinnati, Ohio 45202
United StatesActive - Recruiting
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas 78705
United StatesActive - Recruiting
Intermountain Healthcare
Salt Lake City, Utah 84111
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23219
United StatesActive - Recruiting
Swedish Medical Center
Seattle, Washington 98122
United StatesActive - Recruiting
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