HEAL-IST IDE Trial

Last updated: May 5, 2025
Sponsor: AtriCure, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Defect

Cardiac Disease

Fast Heart Rate (Tachycardia)

Treatment

AtriCure ISOLATOR Synergy Surgical Ablation System

Clinical Study ID

NCT05280093
CP-2021-04
  • Ages 18-75
  • All Genders

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 Criteria

Inclusion

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., ratecontrol drugs such as beta-blockers/calcium channel blockers, ivabradine), and/orAADs

  4. Subject is willing and able to provide written informed consent

Exclusion

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-termbronchodilators use, severe asthma or carcinoid syndrome

  11. Subjects who have had a previous catheter ablation in the right atrium for IST orother 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 adrug, 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 orcaretaker as a legal representative) and;

  19. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements, or impact the scientific soundness of the clinicalinvestigation results

Study Design

Total Participants: 142
Treatment Group(s): 1
Primary Treatment: AtriCure ISOLATOR Synergy Surgical Ablation System
Phase:
Study Start date:
May 31, 2022
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • UZ Brussels

    Brussels,
    Belgium

    Active - Recruiting

  • San Raffaele Hospital

    Milan,
    Italy

    Active - Recruiting

  • Amsterdam University Medical Center

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Maastricht University Medical Center

    Maastricht,
    Netherlands

    Active - Recruiting

  • Central Clinic Hospital

    Warsaw,
    Poland

    Active - Recruiting

  • Northern General Hospital

    Sheffield, S5 7AU
    United Kingdom

    Active - Recruiting

  • Loma Linda University Health

    Loma Linda, California 92354
    United States

    Active - Recruiting

  • Sequoia Hospital

    Redwood City, California 94062
    United States

    Active - Recruiting

  • Stanford University

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut 06606
    United States

    Active - Recruiting

  • Medstar Washington Hospital Center

    Washington, District of Columbia 20010
    United States

    Active - Recruiting

  • University of Florida

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Baptist Health

    Miami, Florida 33143
    United States

    Site Not Available

  • Sarasota Memorial Hospital

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • St. Joseph's Hospital / Baycare Health System

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Active - Recruiting

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho 83706
    United States

    Site Not Available

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • The Christ Hospital

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • TriHealth, Inc.

    Cincinnati, Ohio 45202
    United States

    Active - Recruiting

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Intermountain Healthcare

    Salt Lake City, Utah 84111
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23219
    United States

    Active - Recruiting

  • Swedish Medical Center

    Seattle, Washington 98122
    United States

    Active - Recruiting

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