Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-01-05 @ 9:31 PM
Study NCT ID:
NCT03649594
Status:
UNKNOWN
Last Update Posted:
2020-12-01
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Stratification Post TAVI Using TEG
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2023-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-30', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-08-26', 'lastUpdatePostDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of hypoattenuating leaflet thickening (HALT)', 'timeFrame': '6 months', 'description': 'Presence of HALT on CT scan'}], 'primaryOutcomes': [{'measure': 'Global TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)', 'timeFrame': '6 months', 'description': 'TEG(R)readout Global Hemostasis Assay'}, {'measure': 'Platelet TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)', 'timeFrame': '6 months', 'description': 'TEG(R)readout Platelet Mapping Assay'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality within 12 months', 'timeFrame': '12 months', 'description': 'All-cause mortality will be recorded within 12 months after TAVI.'}, {'measure': 'Cardiovascular mortality within 12 months', 'timeFrame': '12 months', 'description': 'Cardiovascular mortality will be recorded within 12 months after TAVI.'}, {'measure': 'Thromboembolic events within 12 months', 'timeFrame': '12 months', 'description': 'Thromboembolic events will be recorded within 12 months after TAVI.'}, {'measure': 'Bleeding events within 12 months', 'timeFrame': '12 months', 'description': 'Bleeding events will be recorded within 12 months after TAVI.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Platelet Function Tests', 'Predictive Value of Tests', 'Thrombelastography', 'Cardiovascular Diseases', 'Aortic Valve Stenosis', 'Thrombosis', 'Transcatheter Aortic Valve Replacement']}, 'referencesModule': {'references': [{'pmid': '20837923', 'type': 'BACKGROUND', 'citation': 'Ben-Dor I, Pichard AD, Gonzalez MA, Weissman G, Li Y, Goldstein SA, Okubagzi P, Syed AI, Maluenda G, Collins SD, Delhaye C, Wakabayashi K, Gaglia MA Jr, Torguson R, Xue Z, Satler LF, Suddath WO, Kent KM, Lindsay J, Waksman R. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation. 2010 Sep 14;122(11 Suppl):S37-42. doi: 10.1161/CIRCULATIONAHA.109.926873.'}, {'pmid': '26578195', 'type': 'BACKGROUND', 'citation': 'Hamm CW, Arsalan M, Mack MJ. The future of transcatheter aortic valve implantation. Eur Heart J. 2016 Mar 7;37(10):803-10. doi: 10.1093/eurheartj/ehv574. Epub 2015 Nov 17.'}, {'pmid': '27853942', 'type': 'BACKGROUND', 'citation': 'Ruile P, Jander N, Blanke P, Schoechlin S, Reinohl J, Gick M, Rothe J, Langer M, Leipsic J, Buettner HJ, Neumann FJ, Pache G. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol. 2017 Feb;106(2):85-95. doi: 10.1007/s00392-016-1052-3. Epub 2016 Nov 16.'}, {'pmid': '28017712', 'type': 'BACKGROUND', 'citation': 'Yanagisawa R, Hayashida K, Yamada Y, Tanaka M, Yashima F, Inohara T, Arai T, Kawakami T, Maekawa Y, Tsuruta H, Itabashi Y, Murata M, Sano M, Okamoto K, Yoshitake A, Shimizu H, Jinzaki M, Fukuda K. Incidence, Predictors, and Mid-Term Outcomes of Possible Leaflet Thrombosis After TAVR. JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30897-X. doi: 10.1016/j.jcmg.2016.11.005. Online ahead of print.'}, {'pmid': '26436963', 'type': 'BACKGROUND', 'citation': 'Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.'}, {'pmid': '28330690', 'type': 'BACKGROUND', 'citation': 'Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.'}, {'pmid': '28886619', 'type': 'BACKGROUND', 'citation': 'Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.'}, {'pmid': '22438530', 'type': 'BACKGROUND', 'citation': 'Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.'}, {'pmid': '28315732', 'type': 'BACKGROUND', 'citation': "Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available."}, {'pmid': '22473821', 'type': 'BACKGROUND', 'citation': 'Parker RJ, Eley KA, Von Kier S, Pearson O, Watt-Smith SR. Functional fibrinogen to platelet ratio using thromboelastography as a predictive parameter for thrombotic complications following free tissue transfer surgery: a preliminary study. Microsurgery. 2012 Oct;32(7):512-9. doi: 10.1002/micr.21978. Epub 2012 Mar 31.'}, {'pmid': '23696318', 'type': 'BACKGROUND', 'citation': 'Krzanicki D, Sugavanam A, Mallett S. Intraoperative hypercoagulability during liver transplantation as demonstrated by thromboelastography. Liver Transpl. 2013 Aug;19(8):852-61. doi: 10.1002/lt.23668. Epub 2013 Jul 8.'}, {'pmid': '20691842', 'type': 'BACKGROUND', 'citation': 'Gurbel PA, Bliden KP, Navickas IA, Mahla E, Dichiara J, Suarez TA, Antonino MJ, Tantry US, Cohen E. Adenosine diphosphate-induced platelet-fibrin clot strength: a new thrombelastographic indicator of long-term poststenting ischemic events. Am Heart J. 2010 Aug;160(2):346-54. doi: 10.1016/j.ahj.2010.05.034.'}, {'pmid': '26446193', 'type': 'BACKGROUND', 'citation': 'Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7.'}, {'pmid': '17695343', 'type': 'BACKGROUND', 'citation': 'Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.'}]}, 'descriptionModule': {'briefSummary': "Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Current European guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months.The prevalence of subclinical leaflet thrombosis after TAVI is 15% up to 40%, but its clinical long-term relevance is uncertain. Thromboelastography (TEG(R)) can be used as a point-of-care system evaluating a patient's individual hemostasis profile. For the detection of transcatheter valve thrombosis it may be superior to conventional platelet function testing because global hemostasis can be assessed in addition to platelet function. The investigators intend an observational trial recruiting patients undergoing TAVI under standard care. At defined time points the investigators will serially perform TEG(R) as well as further platelet function testing (multiple electrode aggregometry) and conventional coagulation testing. The primary objective is to find surrogate TEG-derived markers / models predicting the development of a subclinical leaflet thrombosis after TAVI under usual care. The secondary objective is to find TEG-derived markers / models identifying patients at an increased risk after TAVI (all-cause mortality, cardiovascular mortality, thromboembolic and bleeding events).", 'detailedDescription': "Aortic stenosis is the most common primary valve disease in high-income countries with increasing importance. Throughout the last 15 years, transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement, the former standard of care. Nowadays, the use of TAVI in elderly patients at increased surgical risk is favored. There is still an important lack of evidence concerning the optimal antithrombotic strategy post TAVI. Recently, it has been shown that the prevalence of subclinical leaflet thrombosis after intervention has been underestimated and may be present in around 15 % up to 40% (PORTICO IDE trial) of transcatheter valves. One study demonstrated that transient ischemic attacks are significantly increased in these patients.\n\nEuropean guidelines are undecided towards the length of the dual antiplatelet therapy (DAPT) after TAVI and recommend optional treatment durations between 3 to 6 months. The optimal duration of DAPT is not known, although DAPT duration is associated with an increased bleeding risk. The most recent update of AHA guidelines for valvular heart disease state that oral anticoagulation with a VKA (INR of 2.5) may be reasonable for at least 3 months after TAVI in patients at low risk of bleeding. Without favoring one over the other recommendation, the current AHA guidelines also maintain the prior statement (from 2014) that clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVI in addition to life-long aspirin, which is in accordance with the European Guideline recommendation. On the other hand, the GALILEO trial has recently been stopped as patients receiving rivaroxaban after TAVI (no prior atrial fibrillation) had a higher mortality and thromboembolic events as well as higher bleeding event rates.\n\nThe TEG(R) 6S analyzer is a point-of-care system evaluating a patient's individual hemostasis profile by thrombelastography (TEG(R)), a potentially superior tool compared to conventional platelet function testing. The TEG(R) system has been able to predict thrombotic complications in different clinical contexts.\n\nIn classic coronary interventional cardiology, the strength of adenosine diphosphate (ADP)-induced and thrombin-induced platelet-fibrin clots were found to be indicators of long-term poststenting ischemic events. As the pathophysiologic mechanism of subclinical leaflet thrombosis has not been examined in detail, the investigators hypothesize that several TEG(R) assays may provide insight in finding predictive TEG(R) markers. Furthermore, as the onset of subclinical leaflet thrombosis is not clear and may possibly increase over time, the design with subsequent TEG(R) analyses at 3 timepoints (0, 3, 6 months) will help to hopefully identify predictors that may become evident at later time points.\n\nIt is intriguing to hypothesize that the better predictive marker may be found using the Global Hemostasis Assay. This is relevant as leaflet thrombosis develops despite dual antiplatelet therapy and anticoagulation has been shown to fully resolve subclinical leaflet thrombosis. The Global Hemostasis Assay may deliver prediction beyond platelet function, which may improve antithrombotic therapy post TAVI. Finding a predictive TEG marker (examining Platelet Mapping and Global Hemostasis together) holds the promise for future individualized clinical decision-making by identifying individual risk.\n\nTaken together, we hope that individual TEG based stratification of patients at risk for subclinical leaflet thrombosis or other events may allow individual clinical decision-making."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team will be possible subjects yielding the eligibility criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients are eligible for enrollment if they are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team.\n\nExclusion Criteria:\n\n* Valve-in-valve TAVI and prior valve thrombosis\n* Severely impaired renal function (e.g. creatinine clearance \\< 30ml/min)\n* poor CT imaging if the presence of HALT cannot be assessed.'}, 'identificationModule': {'nctId': 'NCT03649594', 'acronym': 'RISTRATAVI', 'briefTitle': 'Risk Stratification Post TAVI Using TEG', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Freiburg'}, 'officialTitle': 'Risk Stratification for Subclinical Leaflet Thrombosis Post TAVI Using Thromboelastography', 'orgStudyIdInfo': {'id': 'RISTRATAVI-1-2019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'TAVI and no therapeutic anticoagulation', 'description': 'Subjects in this group do not have an indication for therapeutic anticoagulation.'}, {'label': 'TAVI and therapeutic anticoagulation', 'description': 'Subjects in this group have an indication for therapeutic anticoagulation such as atrial fibrillation.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christoph Olivier, MD', 'role': 'CONTACT', 'email': 'christoph.olivier@universitaets-herzzentrum.de', 'phone': '+49 761 270', 'phoneExt': '34010'}, {'name': 'David Hesselbarth, MD', 'role': 'CONTACT', 'email': 'david.hesselbarth@uniklinik-freiburg.de', 'phone': '+49 761 270', 'phoneExt': '34010'}], 'facility': 'Department of Cardiology and Angiology I, Heart Center Freiburg University', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}], 'centralContacts': [{'name': 'Torben Pottgiesser, MD', 'role': 'CONTACT', 'email': 'torben.pottgiesser@uniklinik-freiburg.de', 'phone': '+49761270', 'phoneExt': '34010'}], 'overallOfficials': [{'name': 'Torben Pottgiesser, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology and Angiology I, Heart Center Freiburg University, Germany'}, {'name': 'Daniel Duerschmied, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cardiology and Angiology I, Heart Center Freiburg University, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torben Pottgiesser', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr. (Assistant Professor)', 'investigatorFullName': 'Torben Pottgiesser', 'investigatorAffiliation': 'University Hospital Freiburg'}}}}