Status:
RECRUITING
HEAL-IST IDE Trial
Lead Sponsor:
AtriCure, Inc.
Conditions:
Inappropriate Sinus Tachycardia
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 opt...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 31 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT05280093
Start Date
May 31 2022
End Date
June 1 2027
Last Update
May 6 2025
Active Locations (26)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354
2
Sequoia Hospital
Redwood City, California, United States, 94062
3
Stanford University
Redwood City, California, United States, 94063
4
Saint Vincent's Medical Center
Bridgeport, Connecticut, United States, 06606