HEAL-IST IDE Trial
- Conditions
- Inappropriate Sinus Tachycardia
- Interventions
- Device: AtriCure ISOLATOR Synergy Surgical Ablation System
- Registration Number
- NCT05280093
- Lead Sponsor
- AtriCure, Inc.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 142
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hybrid sinus node sparing ablation procedure AtriCure ISOLATOR Synergy Surgical Ablation System Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
- Primary Outcome Measures
Name Time Method Primary Effectiveness Endpoint 12-months Post Procedure Freedom from IST at 12-months. Freedom from IST is defined as mean heart rate of ≤ 90bpm or at least a 15% reduction in mean heart rate as compared to baseline, in the absence of new or higher dosage of previously failed medications.
Primary Safety Endpoint 30-days Post Procedure Incidence of device or procedure-related major adverse events (MAEs) for subjects undergoing the hybrid sinus node sparing ablation procedure from the index procedure through 30-days post procedure
- Secondary Outcome Measures
Name Time Method Reduction in mean heart rate in the absence of rate control drugs 24-months Post Procedure Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs
Improved heart rate variability - 7-day monitor 12-months Post Procedure Improved heart rate variability for subjects using 7-day continuous monitoring
6-Minute Walk Test 24-months Post Procedure Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure
Self-Rating Anxiety Scale 24-months Post Procedure Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)
Mean heart rate 24-months Post Procedure Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring
Reduction in mean heart rate regardless of rate control drugs 24-months Post Procedure Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs
Health Economics 24-months Post Procedure Health Economics: ER visits and readmissions
QoL - SF-12 24-months Post Procedure Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure
Device or procedure related Serious Adverse Events 12-months Post Procedure Device or procedure related Serious Adverse Events (SAEs) through 12-months
Borg dyspnea score 24-months Post Procedure Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT.
IST symptom reduction 24-months Post Procedure IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure
Improved heart rate variability - Implantable loop recorder 12-months Post Procedure Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)
Trial Locations
- Locations (26)
Loma Linda University Health
🇺🇸Loma Linda, California, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
San Raffaele Hospital
🇮🇹Milan, Italy
Sequoia Hospital
🇺🇸Redwood City, California, United States
Stanford University
🇺🇸Redwood City, California, United States
Saint Vincent's Medical Center
🇺🇸Bridgeport, Connecticut, United States
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
Medstar Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Baptist Health
🇺🇸Miami, 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
UZ Brussels
🇧🇪Brussels, Belgium
Amsterdam University Medical Center
🇳🇱Amsterdam, Netherlands
Maastricht University Medical Center
🇳🇱Maastricht, Netherlands
Central Clinic Hospital
🇵🇱Warsaw, Poland
Northern General Hospital
🇬🇧Sheffield, United Kingdom