HEAL-IST IDE Trial

Description

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.

Conditions

Inappropriate Sinus Tachycardia

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Study Overview

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Study Details

Study overview

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.

Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia

HEAL-IST IDE Trial

Condition
Inappropriate Sinus Tachycardia
Intervention / Treatment

-

Contacts and Locations

Loma Linda

Loma Linda University Health, Loma Linda, California, United States, 92354

Redwood City

Sequoia Hospital, Redwood City, California, United States, 94062

Redwood City

Stanford University, Redwood City, California, United States, 94063

Bridgeport

Saint Vincent's Medical Center, Bridgeport, Connecticut, United States, 06606

Washington

Medstar Washington Hospital Center, Washington, District of Columbia, United States, 20010

Gainesville

University of Florida, Gainesville, Florida, United States, 32610

Miami

Baptist Health, Miami, Florida, United States, 33143

Sarasota

Sarasota Memorial Hospital, Sarasota, Florida, United States, 34239

Tampa

St. Joseph's Hospital / Baycare Health System, Tampa, Florida, United States, 33607

Savannah

Memorial Health University Medical Center, Savannah, Georgia, United States, 31404

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AtriCure, Inc.,

Dhanunjaya Lakkireddy, MD, PRINCIPAL_INVESTIGATOR, Kansas City Heart Rhythm Institute

Mark La Meir, MD, PRINCIPAL_INVESTIGATOR, Universitair Ziekenhuis Brussel

Carlo de Asmundis, MD, PRINCIPAL_INVESTIGATOR, Universitair Ziekenhuis Brussel

Thomas Beaver, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

2027-06