RECRUITING

HEAL-IST IDE Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-31
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05280093

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.

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

Contacts and Locations

Study Contact

Joseph Derr
CONTACT
1 (866) 349-2342
jderr@atricure.com
Kirstin Smentek
CONTACT
1 (866) 349-2342
ksmentek@atricure.com

Principal Investigator

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 Locations (Sites)

Loma Linda University Health
Loma Linda, California, 92354
United States
Sequoia Hospital
Redwood City, California, 94062
United States
Stanford University
Redwood City, California, 94063
United States
Saint Vincent's Medical Center
Bridgeport, Connecticut, 06606
United States
Medstar Washington Hospital Center
Washington, District of Columbia, 20010
United States
University of Florida
Gainesville, Florida, 32610
United States
Baptist Health
Miami, Florida, 33143
United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239
United States
St. Joseph's Hospital / Baycare Health System
Tampa, Florida, 33607
United States
Memorial Health University Medical Center
Savannah, Georgia, 31404
United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706
United States
Kansas City Cardiac Arrhythmia Research LLC
Overland Park, Kansas, 66211
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
TriHealth, Inc.
Cincinnati, Ohio, 45202
United States
The Christ Hospital
Cincinnati, Ohio, 45219
United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
United States
Intermountain Healthcare
Salt Lake City, Utah, 84111
United States
Virginia Commonwealth University
Richmond, Virginia, 23219
United States
Swedish Medical Center
Seattle, Washington, 98122
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-05-31
Study Completion Date2027-06

Study Record Updates

Study Start Date2022-05-31
Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

  • Inappropriate Sinus Tachycardia