HEAL-IST IDE Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
AtriCure ISOLATOR Synergy Surgical Ablation System: Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (27)
| Facility | City | Region | Status |
|---|---|---|---|
| St. Bernard | Jonesboro | Arkansas | |
| Loma Linda University Health | Loma Linda | California | |
| Sequoia Hospital | Redwood City | California | |
| Stanford University | Redwood City | California | |
| Saint Vincent's Medical Center | Bridgeport | Connecticut | |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | |
| University of Florida | Gainesville | Florida | |
| Baptist Health | Miami | Florida | |
| Sarasota Memorial Hospital | Sarasota | Florida | |
| St. Joseph's Hospital / Baycare Health System | Tampa | Florida | |
| Memorial Health University Medical Center | Savannah | Georgia | |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | |
| Kansas City Cardiac Arrhythmia Research LLC | Overland Park | Kansas | |
| Mayo Clinic | Rochester | Minnesota | |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | |
| TriHealth, Inc. | Cincinnati | Ohio | |
| The Christ Hospital | Cincinnati | Ohio | |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | |
| Intermountain Healthcare | Salt Lake City | Utah | |
| Virginia Commonwealth University | Richmond | Virginia | |
| Swedish Medical Center | Seattle | Washington | |
| 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 |
More AtriCure, Inc. trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05280093 on ClinicalTrials.gov ↗ ← All trials in Italy