Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Active, not recruiting Not applicable

HEAL-IST IDE Trial

NCT05280093 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2022-05-31
Last updated
2026-03-02

Condition(s) studied

Inappropriate Sinus Tachycardia

Investigational drug(s) / intervention(s)

AtriCure ISOLATOR Synergy Surgical Ablation System

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 75 years at time of enrollment consent 2. Subject has a diagnosis of IST 3. 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 4. Subject is willing and able to provide written informed consent Exclusion Criteria: 1. Subjects on whom cardiac surgery or single lung ventilation cannot be performed 2. Subjects with indication for or existing ICDs/Pacemakers 3. Presence of channelopathies 4. Previous cardio-thoracic surgery 5. Left Ventricular Ejection Fraction (LVEF) \< 50% 6. Body Mass Index (BMI) ≥ 35 7. Presence of supraventricular or ventricular tachycardia 8. Presence of Postural Orthostatic Sinus Tachycardia (POTS) 9. Presence of congenital heart disease 10. 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 11. Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders 12. Life expectancy \< 24 months 13. Pregnant or planning to become pregnant during trial 14. Subjects with substance abuse 15. Subjects with previous weight loss surgery 16. Subject is unwilling and/or unable to return for scheduled follow-up visits 17. 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 18. Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and; 19. 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

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)

FacilityCityRegionStatus
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

Official registry record

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