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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid sinus node sparing ablation procedure | Experimental | Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AtriCure ISOLATOR Synergy Surgical Ablation System | Device | Hybrid sinus node sparing ablation procedure using the ISOLATOR Synergy Surgical Ablation System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-months Post Procedure |
| 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 | 30-days Post Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Minute Walk Test | Change in 6-Minute Walk Test (6-MWT) from baseline compared to 6-, 12- and 24-months post-procedure | 24-months Post Procedure |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Bernard | Jonesboro | Arkansas | 72401 | United States | ||
| Loma Linda University Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29931244 | Background | Olshansky B, Sullivan RM. Inappropriate sinus tachycardia. Europace. 2019 Feb 1;21(2):194-207. doi: 10.1093/europace/euy128. | |
| 26310298 | Background | 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. |
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| 24-months Post Procedure |
| 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) | 24-months Post Procedure |
| IST symptom reduction | IST symptom reduction at baseline to 6-, 12- and 24-months post-procedure | 24-months Post Procedure |
| 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 | 24-months Post Procedure |
| Mean heart rate | 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 |
| 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 | 24-months Post Procedure |
| 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 | 24-months Post Procedure |
| Device or procedure related Serious Adverse Events | Device or procedure related Serious Adverse Events (SAEs) through 12-months | 12-months Post Procedure |
| Improved heart rate variability - 7-day monitor | Improved heart rate variability for subjects using 7-day continuous monitoring | 12-months Post Procedure |
| Improved heart rate variability - Implantable loop recorder | Improved heart rate variability and activity levels for subjects with implantable loop recorders (ILRs) | 12-months Post Procedure |
| Health Economics | Health Economics: ER visits and readmissions | 24-months Post Procedure |
| 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 |
| 31077661 | Background | 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. |
| 31084999 | Background | 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. |
| 25980576 | Background | 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. |
| 24721800 | Background | 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. |
| 28250298 | Background | 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. |
| 32479576 | Background | 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. |
| 22981555 | Background | 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. |
| 16077449 | Background | 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. |
| 34424446 | Background | 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. |
| Background | 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. |
| 34339847 | Background | 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. |
| 28506916 | Background | 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. |
| 24697532 | Background | 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. |