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HEAL-IST IDE Trial

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ClinicalTrials.gov Identifier: NCT05280093
Recruitment Status : Recruiting
First Posted : March 15, 2022
Last Update Posted : May 9, 2024
Sponsor:
Information provided by (Responsible Party):
AtriCure, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Inappropriate Sinus Tachycardia Device: AtriCure ISOLATOR Synergy Surgical Ablation System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia
Actual Study Start Date : May 31, 2022
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2027
Arms and Interventions
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Arm Intervention/treatment
Experimental: Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
 Device: AtriCure ISOLATOR Synergy Surgical Ablation System
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System


Outcome Measures
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Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 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.

  2. Primary Safety Endpoint [ Time Frame: 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


Secondary Outcome Measures :
  1. 6-Minute Walk Test [ Time Frame: 24-months Post Procedure ]
    Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure

  2. Borg dyspnea score [ Time Frame: 24-months Post Procedure ]
    Change in Borg dyspnea severity of breathlessness and fatigue score from baseline compared to 6-, 12- and 24-months post-procedure. Borg dyspnea score will be assessed at each of the 6-MWT.

  3. Self-Rating Anxiety Scale [ Time Frame: 24-months Post Procedure ]
    Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)

  4. IST symptom reduction [ Time Frame: 24-months Post Procedure ]
    IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure

  5. QoL - SF-12 [ Time Frame: 24-months Post Procedure ]
    Change in QoL based on a Short Form Survey (SF-12) domain and component scores at baseline compared to 6-, 12- and 24-months post-procedure

  6. Mean heart rate [ Time Frame: 24-months Post Procedure ]
    Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring

  7. Reduction in mean heart rate in the absence of rate control drugs [ Time Frame: 24-months Post Procedure ]
    Freedom from IST or at least 15% reduction in mean heart rate at 12- and 24-months compared to baseline, in the absence of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs

  8. Reduction in mean heart rate regardless of rate control drugs [ Time Frame: 24-months Post Procedure ]
    Freedom from IST or at least a 15% reduction in mean heart rate at 12- and 24-months compared to baseline, regardless of rate control drugs (beta-blockers/calcium channel blockers, ivabradine) and/or AADs

  9. Device or procedure related Serious Adverse Events [ Time Frame: 12-months Post Procedure ]
    Device or procedure related Serious Adverse Events (SAEs) through 12-months

  10. Improved heart rate variability - 7-day monitor [ Time Frame: 12-months Post Procedure ]
    Improved heart rate variability for subjects using 7-day continuous monitoring

  11. Improved heart rate variability - Implantable loop recorder [ Time Frame: 12-months Post Procedure ]
    Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)

  12. Health Economics [ Time Frame: 24-months Post Procedure ]
    Health Economics: ER visits and readmissions


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05280093


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

Locations
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Sponsors and Collaborators
AtriCure, Inc.
Investigators
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Principal Investigator: Dhanunjaya Lakkireddy, MD Kansas City Heart Rhythm Institute
Principal Investigator: Mark La Meir, MD Universitair Ziekenhuis Brussel
Principal Investigator: Carlo de Asmundis, MD Universitair Ziekenhuis Brussel
Principal Investigator: Thomas Beaver, MD University of Florida
More Information
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Publications:
C. De Asmundis et al, "Thoracoscopic Ablation of Inappropriate Sinus Tachycardia and Postural Orthostatic Tachycardia Syndrome." Hands-On-Ablation, The Expert's Approach, Third Edition.
Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

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Responsible Party: AtriCure, Inc.
ClinicalTrials.gov Identifier: NCT05280093    
Other Study ID Numbers: CP-2021-04
First Posted: March 15, 2022    Key Record Dates
Last Update Posted: May 9, 2024
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Tachycardia
Tachycardia, Sinus
Arrhythmias, Cardiac
Heart Diseases
 Cardiovascular Diseases
Cardiac Conduction System Disease
Pathologic Processes
Tachycardia, Supraventricular