HEAL-IST IDE-proef
3 november 2026 bijgewerkt door: AtriCure, Inc.
Hybride epicardiale en endocardiale sinusknoopsparende ablatietherapie voor ongepaste sinustachycardie
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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
100
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Brussels, België
- UZ Brussels
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Milan, Italië
- San Raffaele Hospital
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Amsterdam, Nederland
- Amsterdam University Medical Center
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Maastricht, Nederland
- Maastricht University Medical Center
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Warsaw, Polen
- Central Clinic Hospital
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Sheffield, Verenigd Koninkrijk, S5 7AU
- Northern General Hospital
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Arkansas
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Jonesboro, Arkansas, Verenigde Staten, 72401
- St. Bernard
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California
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Loma Linda, California, Verenigde Staten, 92354
- Loma Linda University Health
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Redwood City, California, Verenigde Staten, 94063
- Stanford University
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Redwood City, California, Verenigde Staten, 94062
- Sequoia Hospital
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Connecticut
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Bridgeport, Connecticut, Verenigde Staten, 06606
- Saint Vincent's Medical Center
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District of Columbia
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Washington D.C., District of Columbia, Verenigde Staten, 20010
- Medstar Washington Hospital Center
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Florida
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Gainesville, Florida, Verenigde Staten, 32610
- University of Florida
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Miami, Florida, Verenigde Staten, 33143
- Baptist Health
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Sarasota, Florida, Verenigde Staten, 34239
- Sarasota Memorial Hospital
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Tampa, Florida, Verenigde Staten, 33607
- St. Joseph's Hospital / Baycare Health System
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Georgia
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Savannah, Georgia, Verenigde Staten, 31404
- Memorial Health University Medical Center
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Idaho
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Boise, Idaho, Verenigde Staten, 83706
- Saint Alphonsus Regional Medical Center
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Kansas
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Overland Park, Kansas, Verenigde Staten, 66211
- Kansas City Cardiac Arrhythmia Research LLC
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Minnesota
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Rochester, Minnesota, Verenigde Staten, 55905
- Mayo Clinic
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North Carolina
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Winston-Salem, North Carolina, Verenigde Staten, 27157
- Wake Forest University Health Sciences
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45219
- The Christ Hospital
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Cincinnati, Ohio, Verenigde Staten, 45202
- TriHealth, Inc.
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Texas
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Austin, Texas, Verenigde Staten, 78705
- Texas Cardiac Arrhythmia Research Foundation
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Utah
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Salt Lake City, Utah, Verenigde Staten, 84111
- Intermountain Healthcare
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Virginia
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Richmond, Virginia, Verenigde Staten, 23219
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Verenigde Staten, 98122
- Swedish Medical Center
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 75 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Hybrid sinus node sparing ablation procedure
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Primary Effectiveness Endpoint
Tijdsspanne: 12-months Post Procedure
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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. |
12-months Post Procedure
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Primary Safety Endpoint
Tijdsspanne: 30-days Post Procedure
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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 |
30-days Post Procedure
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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6-Minute Walk Test
Tijdsspanne: 24-months Post Procedure
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Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure |
24-months Post Procedure
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Borg dyspnea score
Tijdsspanne: 24-months Post Procedure
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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. |
24-months Post Procedure
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Self-Rating Anxiety Scale
Tijdsspanne: 24-months Post Procedure
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Change from baseline in psychological evaluation compared to 6-, 12- and 24-months post-procedure utilizing the Self-Rating Anxiety Scale (SAS) |
24-months Post Procedure
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IST symptom reduction
Tijdsspanne: 24-months Post Procedure
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IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure |
24-months Post Procedure
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QoL - SF-12
Tijdsspanne: 24-months Post Procedure
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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 |
24-months Post Procedure
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Mean heart rate
Tijdsspanne: 24-months Post Procedure
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Change in mean heart rate at 6-, 12- and 24-months post-procedure compared to baseline, using 7-day continuous monitoring |
24-months Post Procedure
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Reduction in mean heart rate in the absence of rate control drugs
Tijdsspanne: 24-months Post Procedure
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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 |
24-months Post Procedure
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Reduction in mean heart rate regardless of rate control drugs
Tijdsspanne: 24-months Post Procedure
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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 |
24-months Post Procedure
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Device or procedure related Serious Adverse Events
Tijdsspanne: 12-months Post Procedure
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Device or procedure related Serious Adverse Events (SAEs) through 12-months |
12-months Post Procedure
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Improved heart rate variability - 7-day monitor
Tijdsspanne: 12-months Post Procedure
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Improved heart rate variability for subjects using 7-day continuous monitoring |
12-months Post Procedure
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Improved heart rate variability - Implantable loop recorder
Tijdsspanne: 12-months Post Procedure
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Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs) |
12-months Post Procedure
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Health Economics
Tijdsspanne: 24-months Post Procedure
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Health Economics: ER visits and readmissions |
24-months Post Procedure
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Dhanunjaya Lakkireddy, MD, Kansas City Heart Rhythm Institute
- Hoofdonderzoeker: Mark La Meir, MD, Universitair Ziekenhuis Brussel
- Hoofdonderzoeker: Carlo de Asmundis, MD, Universitair Ziekenhuis Brussel
- Hoofdonderzoeker: Thomas Beaver, MD, University of Florida
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
- Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
31 mei 2022
Primaire voltooiing (Geschat)
1 februari 2027
Studie voltooiing (Geschat)
1 februari 2028
Studieregistratiedata
Eerst ingediend
4 maart 2022
Eerst ingediend dat voldeed aan de QC-criteria
4 maart 2022
Eerst geplaatst (Werkelijk)
15 maart 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
5 november 2026
Laatste update ingediend die voldeed aan QC-criteria
3 november 2026
Laatst geverifieerd
1 november 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- CP-2021-04
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Ja
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .