CClinicalTrials.gg
Sign In
Active, not recruitingNCT05280093Updated Mar 2, 2026

HEAL-IST IDE Trial

An interventional study of AtriCure ISOLATOR Synergy Surgical Ablation System in Inappropriate Sinus Tachycardia, sponsored by AtriCure, Inc.. Active, not recruiting at 27 sites in 6 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-02.

Sponsored by AtriCure, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
142
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

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.

02

Conditions studied

  • Inappropriate Sinus Tachycardia
03

In context

Lead sponsor

AtriCure, Inc. is the lead sponsor of 31 studies on the registry; 5 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
142 participants (estimated)

Study arms

  • 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

Interventions

  • DeviceAtriCure ISOLATOR Synergy Surgical Ablation System

    Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System

06

What researchers measure

Primary outcomes

  1. Primary Effectiveness Endpoint

    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.

    Time frame: 12-months Post Procedure

  2. Primary Safety Endpoint

    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

    Time frame: 30-days Post Procedure

Secondary outcomes

  1. 6-Minute Walk Test

    Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure

    Time frame: 24-months Post Procedure

  2. Borg dyspnea score

    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.

    Time frame: 24-months Post Procedure

  3. Self-Rating Anxiety Scale

    Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS)

    Time frame: 24-months Post Procedure

  4. IST symptom reduction

    IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure

    Time frame: 24-months Post Procedure

  5. QoL - SF-12

    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

    Time frame: 24-months Post Procedure

  6. Mean heart rate

    Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring

    Time frame: 24-months Post Procedure

  7. Reduction in mean heart rate in the absence of rate control drugs

    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

    Time frame: 24-months Post Procedure

  8. Reduction in mean heart rate regardless of rate control drugs

    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

    Time frame: 24-months Post Procedure

  9. Device or procedure related Serious Adverse Events

    Device or procedure related Serious Adverse Events (SAEs) through 12-months

    Time frame: 12-months Post Procedure

  10. Improved heart rate variability - 7-day monitor

    Improved heart rate variability for subjects using 7-day continuous monitoring

    Time frame: 12-months Post Procedure

  11. Improved heart rate variability - Implantable loop recorder

    Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs)

    Time frame: 12-months Post Procedure

  12. Health Economics

    Health Economics: ER visits and readmissions

    Time frame: 24-months Post Procedure

07

Study locations

27 sites
  • St. Bernard
    Jonesboro, Arkansas 72401, United States
  • 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 D.C., 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
  • 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, S5 7AU, United Kingdom
08

References and documents

Publications

  • Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128. PubMed 29931244 ↗
  • Pellegrini CN, Scheinman MM. Epidemiology and definition of inappropriate sinus tachycardia. J Interv Card Electrophysiol. 2016 Jun;46(1):29-32. doi: 10.1007/s10840-015-0039-8. Epub 2015 Aug 27. PubMed 26310298 ↗
  • Khiabani AJ, Greenberg JW, Hansalia VH, Schuessler RB, Melby SJ, Damiano RJ Jr. Late Outcomes of Surgical Ablation for Inappropriate Sinus Tachycardia. Ann Thorac Surg. 2019 Oct;108(4):1162-1168. doi: 10.1016/j.athoracsur.2019.03.103. Epub 2019 May 8. PubMed 31077661 ↗
  • de Asmundis C, Chierchia GB, Sieira J, Stroker E, Umbrain V, Poelaert J, Brugada P, La Meir M. Sinus Node Sparing Novel Hybrid Approach for Treatment of Inappropriate Sinus Tachycardia/Postural Orthostatic Sinus Tachycardia With New Electrophysiological Finding. Am J Cardiol. 2019 Jul 15;124(2):224-232. doi: 10.1016/j.amjcard.2019.04.019. Epub 2019 Apr 23. PubMed 31084999 ↗
  • Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available. PubMed 25980576 ↗
  • Nwazue VC, Paranjape SY, Black BK, Biaggioni I, Diedrich A, Dupont WD, Robertson D, Raj SR. Postural tachycardia syndrome and inappropriate sinus tachycardia: role of autonomic modulation and sinus node automaticity. J Am Heart Assoc. 2014 Apr 10;3(2):e000700. doi: 10.1161/JAHA.113.000700. PubMed 24721800 ↗
  • Masumoto A, Takemoto M, Mito T, Tanaka A, Kawano Y, Kumeda H, Kang H, Matsuo A, Hida S, Okazaki T, Tayama KI, Yoshitake K, Kosuga K. Inappropriate Sinus Tachycardia Diagnosed and Treated as Depression Successfully Treated by Radiofrequency Catheter Ablation. Intern Med. 2017;56(5):523-526. doi: 10.2169/internalmedicine.56.7579. Epub 2017 Mar 1. PubMed 28250298 ↗
  • Yasin OZ, Vaidya VR, Chacko SR, Asirvatham SJ. Inappropriate Sinus Tachycardia: Current Challenges and Future Directions. J Innov Card Rhythm Manag. 2018 Jul 15;9(7):3239-3243. doi: 10.19102/icrm.2018.090706. eCollection 2018 Jul. No abstract available. PubMed 32479576 ↗
  • Cappato R, Castelvecchio S, Ricci C, Bianco E, Vitali-Serdoz L, Gnecchi-Ruscone T, Pittalis M, De Ambroggi L, Baruscotti M, Gaeta M, Furlanello F, Di Francesco D, Lupo PP. Clinical efficacy of ivabradine in patients with inappropriate sinus tachycardia: a prospective, randomized, placebo-controlled, double-blind, crossover evaluation. J Am Coll Cardiol. 2012 Oct 9;60(15):1323-9. doi: 10.1016/j.jacc.2012.06.031. Epub 2012 Sep 12. PubMed 22981555 ↗
  • Kreisel D, Bailey M, Lindsay BD, Damiano RJ Jr. A minimally invasive surgical treatment for inappropriate sinus tachycardia. J Thorac Cardiovasc Surg. 2005 Aug;130(2):598-9. doi: 10.1016/j.jtcvs.2004.12.026. No abstract available. PubMed 16077449 ↗
  • de Asmundis C, Chierchia GB, Lakkireddy D, Romeya A, Okum E, Gandhi G, Sieira J, Vloka M, Jones SD, Shah H, Winner M, Patel D, Whalen SP, Beaty EH, Kincaid EH, Lee A, Brodt C, Taylor BJ, Colombowala I, Romano M, Morady F, Stroker E, Overeinder I, Bala G, Van Meeteren J, Krauthammer Y, Koerber S, Shults C, Thomaides A, Badhwar N, Gopinathannair R, Shah A, Tummala R, Bello D, Hoff S, Almorad A, Frazier K, Brugada P, La Meir M. Sinus node sparing novel hybrid approach for treatment of inappropriate sinus tachycardia/postural sinus tachycardia: multicenter experience. J Interv Card Electrophysiol. 2022 Apr;63(3):531-544. doi: 10.1007/s10840-021-01044-5. Epub 2021 Aug 23. PubMed 34424446 ↗
  • 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.
  • Lakkireddy D, Garg J, DeAsmundis C, LaMeier M, Romeya A, Vanmeetren J, Park P, Tummala R, Koerber S, Vasamreddy C, Shah A, Shivamurthy P, Frazier K, Awasthi Y, Chierchia GB, Atkins D, Bommana S, Di Biase L, Al-Ahmad A, Natale A, Gopinathannair R. Sinus Node Sparing Hybrid Thoracoscopic Ablation Outcomes in Patients with Inappropriate Sinus Tachycardia (SUSRUTA-IST) Registry. Heart Rhythm. 2022 Jan;19(1):30-38. doi: 10.1016/j.hrthm.2021.07.010. Epub 2021 Jul 30. PubMed 34339847 ↗
  • 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. PubMed 28506916 ↗
  • Broglio KR, Connor JT, Berry SM. Not too big, not too small: a goldilocks approach to sample size selection. J Biopharm Stat. 2014;24(3):685-705. doi: 10.1080/10543406.2014.888569. PubMed 24697532 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05280093
Lead sponsor
AtriCure, Inc.
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
May 31, 2022
Primary completion
Feb 2027 (estimated)
Completion
Feb 2028 (estimated)
Last update
Mar 2, 2026

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

AtriCure, Inc.

Start the discussion