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Inappropriate Sinus TachycardiaNCT05280093

HEAL-IST IDE Trial

A study testing AtriCure ISOLATOR Synergy Surgical Ablation System in people with Inappropriate Sinus Tachycardia, run by AtriCure, Inc. at 27 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Inappropriate Sinus Tachycardia
What is being tested?
AtriCure ISOLATOR Synergy Surgical Ablation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
142 participants
Where
27 sitesin 6 countries
Study dates
31 May 2022to Feb 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years and ≤ 75 years at time of enrollment consent
  • Subject has a diagnosis of IST
  • 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
  • Subject is willing and able to provide written informed consent

Who cannot join

  • Subjects on whom cardiac surgery or single lung ventilation cannot be performed
  • Subjects with indication for or existing ICDs/Pacemakers
  • Presence of channelopathies
  • Previous cardio-thoracic surgery
  • Left Ventricular Ejection Fraction (LVEF) < 50%
  • Body Mass Index (BMI) ≥ 35
Show all 19Show fewer
  • Presence of supraventricular or ventricular tachycardia
  • Presence of Postural Orthostatic Sinus Tachycardia (POTS)
  • Presence of congenital heart disease
  • 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
  • Subjects who have had a previous catheter ablation in the right atrium for IST or other disorders
  • Life expectancy < 24 months
  • Pregnant or planning to become pregnant during trial
  • Subjects with substance abuse
  • Subjects with previous weight loss surgery
  • Subject is unwilling and/or unable to return for scheduled follow-up visits
  • 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
  • Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative) and;
  • 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

Trial locations and contacts

27 sites in 6 countries.

27 sites in 6 countries

United States21 sites

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas, 78705

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Saint Vincent's Medical Center

    Bridgeport, Connecticut, 06606

  • TriHealth, Inc.

    Cincinnati, Ohio, 45202

  • The Christ Hospital

    Cincinnati, Ohio, 45219

  • University of Florida

    Gainesville, Florida, 32610

  • St. Bernard

    Jonesboro, Arkansas, 72401

  • Loma Linda University Health

    Loma Linda, California, 92354

  • Baptist Health

    Miami, Florida, 33143

  • Kansas City Cardiac Arrhythmia Research LLC

    Overland Park, Kansas, 66211

  • Sequoia Hospital

    Redwood City, California, 94062

  • Stanford University

    Redwood City, California, 94063

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Intermountain Healthcare

    Salt Lake City, Utah, 84111

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Swedish Medical Center

    Seattle, Washington, 98122

  • St. Joseph's Hospital / Baycare Health System

    Tampa, Florida, 33607

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

Netherlands2 sites

  • Amsterdam University Medical Center

    Amsterdam

  • Maastricht University Medical Center

    Maastricht

Other trials in Netherlands

Belgium1 site

  • UZ Brussels

    Brussels

Other trials in Belgium

Italy1 site

  • San Raffaele Hospital

    Milan

Other trials in Italy

Poland1 site

  • Central Clinic Hospital

    Warsaw

Other trials in Poland

United Kingdom1 site

  • Northern General Hospital

    Sheffield, S5 7AU

Other trials in United Kingdom

About this study

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

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.

Being tested
AtriCure ISOLATOR Synergy Surgical Ablation System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtriCure ISOLATOR Synergy Surgical Ablation SystemDevice

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

Study groups in NCT05280093
Study groupRoleWhat they receive
Hybrid sinus node sparing ablation procedureExperimentalHybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System
Receives: Device: AtriCure ISOLATOR Synergy Surgical Ablation System

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

    Measured: 30-days Post Procedure

Secondary outcomes (12)

  1. 6-Minute Walk Test

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

    Measured: 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.

    Measured: 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)

    Measured: 24-months Post Procedure

  4. IST symptom reduction

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 24-months Post Procedure

  9. Device or procedure related Serious Adverse Events

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

    Measured: 12-months Post Procedure

  10. Improved heart rate variability - 7-day monitor

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

    Measured: 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)

    Measured: 12-months Post Procedure

  12. Health Economics

    Health Economics: ER visits and readmissions

    Measured: 24-months Post Procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2022
  2. Study start31 May 2022
  3. Primary completionFeb 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
142 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05280093
Sponsor's protocol ID
CP-2021-04
Status last verified
Feb 2026
First submitted
4 Mar 2022
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing AtriCure ISOLATOR Synergy Surgical Ablation System in people with Inappropriate Sinus Tachycardia, run by AtriCure, Inc. at 27 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Netherlands, Belgium, Italy, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Effectiveness Endpoint (time frame: 12-months Post Procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05280093, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.

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