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HEAL-IST IDE Trial
Sponsor: AtriCure, Inc.
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.
Official title: Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2022-05-31
Completion Date
2028-02
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
AtriCure ISOLATOR Synergy Surgical Ablation System
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Locations (27)
St. Bernard
Jonesboro, Arkansas, United States
Loma Linda University Health
Loma Linda, California, United States
Sequoia Hospital
Redwood City, California, United States
Stanford University
Redwood City, California, United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Baptist Health
Miami, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
St. Joseph's Hospital / Baycare Health System
Tampa, Florida, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, United States
Mayo Clinic
Rochester, Minnesota, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
TriHealth, Inc.
Cincinnati, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Intermountain Healthcare
Salt Lake City, Utah, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
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