HEAL-IST IDE Trial

Running, not enrolling · Not applicable

Conditions studied: Inappropriate Sinus Tachycardia

In brief

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.

Key facts

Study ID

NCT05280093

Run by

AtriCure, Inc.

People needed

142

Starts

2022-05-31

Expected to finish

2028-02-01

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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., rate control drugs such as beta-blockers/calcium channel blockers, ivabradine), and/or AADs
• Subject is willing and able to provide written informed consent

You may not qualify if…

• 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-term bronchodilators use, severe asthma or carcinoid syndrome
• Subjects who have had a previous catheter ablation in the right atrium for IST or other 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 a drug, 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 or caretaker as a legal representative) and;
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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