Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Total Enrollment
20000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2011-02-28
Study Completion Date
2025-05-31
Brief Summary
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The purpose of this prospective multi-center, observational national registry in Switzerland is to obtain clinical baseline, procedural and follow-up data of all patients treated with TAVI in Switzerland and to assess short, mid- and long-term clinical outcome data of the CE approved devices. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to include patients in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to five years.
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Detailed Description
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The present registry aims to assess the safety and efficacy of TAVI with CE approved devices at Swiss cardiovascular centers. The Swiss Working group of Interventional Cardiology and Acute Coronary Syndrome decided to establish a nationwide registry in collaboration with the Swiss Society of Cardiac Surgery in order to assess the procedural and clinical outcome of TAVI patients. This prospective registry will help to identify candidates for TAVI, will report on peri-procedural outcome and on long-term efficacy of the devices. Last but not least it is a tool to increase quality of treatment of this high-risk patient population.
Methods
This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.
Methods
This is a prospective multi-center, observational registry performed in Switzerland. All centers in Switzerland implanting the CE approved devices for TAVI will be invited to consecutively include patients in the registry. Each center will sign an agreement that all patients will be included in the registry. Each site will collect baseline and procedural data as well as clinical outcome data up to 15 years after TAVI.
Conditions
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Aortic Valve Disease Mixed
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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1
Patients with native aortic stenosis undergoing TAVI
Transcatheter Aortic Valve Implantation
Intervention Type
PROCEDURE
Minimal Invasive Implantation of a biological prosthesis in Aortic Position
2
Patients with native aortic regurgitation undergoing TAVI
No interventions assigned to this group
3
Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV
No interventions assigned to this group
Interventions
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Transcatheter Aortic Valve Implantation
Minimal Invasive Implantation of a biological prosthesis in Aortic Position
Intervention Type
PROCEDURE
Eligibility Criteria
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Inclusion Criteria
* Native aortic valve stenosis
* Native aortic valve regurgitation
* Degenerated aortic bioprosthesis requiring treatment
* Native aortic valve regurgitation
* Degenerated aortic bioprosthesis requiring treatment
Exclusion Criteria
* Patients refuses informed consent to participate in the registry
* Contraindication for TAVI
* High probability of non-adherence to the follow up - requirements
* Contraindication for TAVI
* High probability of non-adherence to the follow up - requirements
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Insel Gruppe AG, University Hospital Bern
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Stefan Stortecky, MD
Role: STUDY_CHAIR
Bern University Hospital
Locations
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Department of Cardiology
Bern, , Switzerland
Site Status
RECRUITING
Department of Cardiology
Bern, , Switzerland
Site Status
RECRUITING
Countries
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Switzerland
Central Contacts
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Facility Contacts
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References
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Tomii D, Alaour B, Heg D, Okuno T, Nakase M, Samim D, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Self-expanding versus balloon-expandable transcatheter heart valves in patients with excessive aortic valve cusp calcification. Am Heart J. 2025 Sep 18;292:107279. doi: 10.1016/j.ahj.2025.09.011. Online ahead of print.
Reference Type
DERIVED
Badertscher P, Stortecky S, Serban T, Knecht S, Heg D, Tueller D, Jeger R, Reuthebuch O, Muller O, Toggweiler S, Wenaweser P, Huber C, Roffi M, Ferrari E, Reichlin T, Nestelberger T, Mahfoud F, Kuhne M, Sticherling C; SwissTAVI Investigators. Long-Term Outcomes of Patients Requiring Pacemaker Implantation After Transcatheter Aortic Valve Replacement: The SwissTAVI Registry. JACC Cardiovasc Interv. 2025 May 12;18(9):1163-1171. doi: 10.1016/j.jcin.2025.03.028. Epub 2025 Apr 1.
Reference Type
DERIVED
Nakase M, Draxler DF, Tomii D, Heg D, Okuno T, Samim D, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Incidence, predictors and clinical impact of upper gastrointestinal bleeding after transcatheter aortic valve replacement. Heart. 2025 May 10:heartjnl-2024-325359. doi: 10.1136/heartjnl-2024-325359. Online ahead of print.
Reference Type
DERIVED
Tomii D, Heg D, Nakase M, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Flow Status-Based Predicted Prosthesis-Patient Mismatch in Patients Undergoing Transcatheter Aortic Valve Replacement With a Balloon-Expandable Valve. Struct Heart. 2024 Dec 6;9(4):100379. doi: 10.1016/j.shj.2024.100379. eCollection 2025 Apr.
Reference Type
DERIVED
Nakase M, Tomii D, Maznyczka A, Heg D, Okuno T, Samim D, Stortecky S, Lanz J, Reineke D, Windecker S, Pilgrim T. Five-year outcomes with self-expanding versus balloon-expandable TAVI in patients with left ventricular systolic dysfunction. Am Heart J. 2025 Feb;280:18-29. doi: 10.1016/j.ahj.2024.10.018. Epub 2024 Nov 12.
Reference Type
DERIVED
Nakase M, Tomii D, Samim D, Grani C, Praz F, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of Severity and Extent of Iliofemoral Atherosclerosis on Clinical Outcomes in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2024 Oct 28;17(20):2353-2363. doi: 10.1016/j.jcin.2024.07.009. Epub 2024 Oct 9.
Reference Type
DERIVED
Tomii D, Heg D, Lanz J, Nakase M, Samim D, Stortecky S, Reineke D, Windecker S, Pilgrim T. Renin-Angiotensin System Inhibition in Patients With Myocardial Injury Complicating Transcatheter Aortic Valve Replacement. JACC Adv. 2024 Aug 16;3(9):101212. doi: 10.1016/j.jacadv.2024.101212. eCollection 2024 Sep.
Reference Type
DERIVED
Tomii D, Okuno T, Nakase M, Praz F, Stortecky S, Reineke D, Windecker S, Lanz J, Pilgrim T. Renin-Angiotensin System Inhibition and Cardiac Damage in Patients Undergoing Transcatheter Aortic Valve Replacement. Can J Cardiol. 2024 Dec;40(12):2592-2602. doi: 10.1016/j.cjca.2024.07.019. Epub 2024 Jul 25.
Reference Type
DERIVED
Nakase M, Tomii D, Maznyczka A, Samim D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Sex-Specific Differences in Upstream Cardiac Damage in Patients With Aortic Stenosis Undergoing TAVR. JACC Cardiovasc Interv. 2024 May 27;17(10):1252-1264. doi: 10.1016/j.jcin.2024.03.031.
Reference Type
DERIVED
Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Reineke D, Samim D, Lanz J, Windecker S, Pilgrim T. Long-Term Impact of Cardiac Damage Following Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2024 Apr 22;17(8):992-1003. doi: 10.1016/j.jcin.2024.02.011.
Reference Type
DERIVED
Alaour B, Ferrari E, Heg D, Tueller D, Pilgrim T, Muller O, Noble S, Jeger R, Reuthebuch O, Toggweiler S, Templin C, Wenaweser P, Nietlispach F, Taramasso M, Huber C, Roffi M, Windecker S, Stortecky S. Non-Vitamin K Antagonist Versus Vitamin K Antagonist Oral Anticoagulant Agents After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2024 Feb 12;17(3):405-418. doi: 10.1016/j.jcin.2023.11.038.
Reference Type
DERIVED
Okuno T, Alaour B, Heg D, Tueller D, Pilgrim T, Muller O, Noble S, Jeger R, Reuthebuch O, Toggweiler S, Ferrari E, Templin C, Wenaweser P, Nietlispach F, Taramasso M, Huber C, Roffi M, Windecker S, Stortecky S. Long-Term Risk of Stroke After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry. JACC Cardiovasc Interv. 2023 Dec 25;16(24):2986-2996. doi: 10.1016/j.jcin.2023.10.021.
Reference Type
DERIVED
Tomii D, Okuno T, Heg D, Nakase M, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Long-term outcomes of measured and predicted prosthesis-patient mismatch following transcatheter aortic valve replacement. EuroIntervention. 2023 Nov 17;19(9):746-756. doi: 10.4244/EIJ-D-23-00456.
Reference Type
DERIVED
Nakase M, Tomii D, Heg D, Praz F, Stortecky S, Lanz J, Reineke D, Windecker S, Pilgrim T. Association of atrial fibrillation with survival in patients with low-flow low-gradient aortic stenosis with preserved ejection fraction undergoing TAVI. Eur Heart J Qual Care Clin Outcomes. 2024 May 22;10(3):246-255. doi: 10.1093/ehjqcco/qcad045.
Reference Type
DERIVED
Alwan L, Tomii D, Heg D, Okuno T, Lanz J, Praz F, Chong-Nguyen C, Stortecky S, Reineke D, Windecker S, Pilgrim T. Impact of right ventricular-pulmonary arterial coupling on clinical outcomes in patients undergoing transcatheter aortic valve implantation. Cardiovasc Revasc Med. 2023 Nov;56:27-34. doi: 10.1016/j.carrev.2023.05.008. Epub 2023 May 16.
Reference Type
DERIVED
Okuno T, Tomii D, Lanz J, Heg D, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. 5-Year Outcomes With Self-Expanding vs Balloon-Expandable Transcatheter Aortic Valve Replacement in Patients With Small Annuli. JACC Cardiovasc Interv. 2023 Feb 27;16(4):429-440. doi: 10.1016/j.jcin.2022.11.032.
Reference Type
DERIVED
Tomii D, Okuno T, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Valve-in-valve TAVI and risk of coronary obstruction: Validation of the VIVID classification. J Cardiovasc Comput Tomogr. 2023 Mar-Apr;17(2):105-111. doi: 10.1016/j.jcct.2023.01.042. Epub 2023 Feb 6.
Reference Type
DERIVED
Tomii D, Okuno T, Lanz J, Stortecky S, Windecker S, Pilgrim T. Aortic annulus ellipticity and outcomes after transcatheter aortic valve implantation. Catheter Cardiovasc Interv. 2023 Jan;101(1):199-208. doi: 10.1002/ccd.30507. Epub 2022 Dec 1.
Reference Type
DERIVED
Okuno T, Demirel C, Tomii D, Heg D, Haner J, Siontis GCM, Lanz J, Raber L, Strotecky S, Furholz M, Praz F, Windecker S, Pilgrim T. Long-term risk of unplanned percutaneous coronary intervention after transcatheter aortic valve replacement. EuroIntervention. 2022 Nov 18;18(10):797-803. doi: 10.4244/EIJ-D-22-00342.
Reference Type
DERIVED
Mergen V, Sartoretti T, Baer-Beck M, Schmidt B, Petersilka M, Wildberger JE, Euler A, Eberhard M, Alkadhi H. Ultra-High-Resolution Coronary CT Angiography With Photon-Counting Detector CT: Feasibility and Image Characterization. Invest Radiol. 2022 Dec 1;57(12):780-788. doi: 10.1097/RLI.0000000000000897. Epub 2022 May 31.
Reference Type
DERIVED
Okuno T, Tomii D, Buffle E, Lanz J, Ryffel C, Demirel C, Hashemi S, Hagemeyer D, Papadis A, Heg D, Praz F, Stortecky S, Windecker S, Pilgrim T. Transcatheter aortic valve implantation in patients with rheumatic aortic stenosis. Heart. 2022 Jul 13;108(15):1225-1233. doi: 10.1136/heartjnl-2021-320531.
Reference Type
DERIVED
Tomii D, Okuno T, Demirel C, Praz F, Lanz J, Stortecky S, Windecker S, Pilgrim T. Impact of First-Phase Ejection Fraction on Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation. Cardiovasc Revasc Med. 2022 Sep;42:55-61. doi: 10.1016/j.carrev.2022.02.023. Epub 2022 Feb 26.
Reference Type
DERIVED
Tomii D, Okuno T, Heg D, Lanz J, Praz F, Stortecky S, Windecker S, Pilgrim T. Validation of the VARC-3 Technical Success Definition in Patients Undergoing TAVR. JACC Cardiovasc Interv. 2022 Feb 28;15(4):353-364. doi: 10.1016/j.jcin.2021.11.013. Epub 2022 Jan 31.
Reference Type
DERIVED
Mergen V, Sartoretti T, Klotz E, Schmidt B, Jungblut L, Higashigaito K, Manka R, Euler A, Kasel M, Eberhard M, Alkadhi H. Extracellular Volume Quantification With Cardiac Late Enhancement Scanning Using Dual-Source Photon-Counting Detector CT. Invest Radiol. 2022 Jun 1;57(6):406-411. doi: 10.1097/RLI.0000000000000851. Epub 2022 Jan 21.
Reference Type
DERIVED
Okuno T, Tomii D, Heg D, Lanz J, Praz F, Stortecky S, Reineke D, Windecker S, Pilgrim T. Five-year outcomes of mild paravalvular regurgitation after transcatheter aortic valve implantation. EuroIntervention. 2022 May 15;18(1):33-42. doi: 10.4244/EIJ-D-21-00784.
Reference Type
DERIVED
Tomii D, Okuno T, Heg D, Grani C, Lanz J, Praz F, Stortecky S, Windecker S, Pilgrim T, Reineke D. Sinus of Valsalva Dimension and Clinical Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation. Am Heart J. 2022 Feb;244:94-106. doi: 10.1016/j.ahj.2021.11.004. Epub 2021 Nov 14.
Reference Type
DERIVED
Tomii D, Okuno T, Praz F, Heg D, Wild MG, Lanz J, Stortecky S, Reineke D, Windecker S, Pilgrim T. Potential Candidates for Transcatheter Tricuspid Valve Intervention After Transcatheter Aortic Valve Replacement: Predictors and Prognosis. JACC Cardiovasc Interv. 2021 Oct 25;14(20):2246-2256. doi: 10.1016/j.jcin.2021.07.030. Epub 2021 Sep 29.
Reference Type
DERIVED
Okuno T, Lanz J, Stortecky S, Heg D, Bernhard B, Grani C, Huber A, Praz F, Raber L, Valgimigli M, Siontis GCM, Windecker S, Pilgrim T. Clinical impact of left atrial appendage filling defects in patients undergoing transcatheter aortic valve implantation. Eur Heart J Cardiovasc Imaging. 2022 Sep 10;23(10):1354-1364. doi: 10.1093/ehjci/jeab142.
Reference Type
DERIVED
Eberhard M, Hinzpeter R, Schonenberger ALN, Euler A, Kuzo N, Reeve K, Stahli BE, Kasel AM, Manka R, Tanner FC, Alkadhi H. Incremental Prognostic Value of Coronary Artery Calcium Score for Predicting All-Cause Mortality after Transcatheter Aortic Valve Replacement. Radiology. 2021 Oct;301(1):105-112. doi: 10.1148/radiol.2021204623. Epub 2021 Aug 3.
Reference Type
DERIVED
Okuno T, Heg D, Lanz J, Praz F, Brugger N, Stortecky S, Windecker S, Pilgrim T. Refined staging classification of cardiac damage associated with aortic stenosis and outcomes after transcatheter aortic valve implantation. Eur Heart J Qual Care Clin Outcomes. 2021 Oct 28;7(6):532-541. doi: 10.1093/ehjqcco/qcab041.
Reference Type
DERIVED
Attinger-Toller A, Ferrari E, Tueller D, Templin C, Muller O, Nietlispach F, Toggweiler S, Noble S, Roffi M, Jeger R, Huber C, Carrel T, Pilgrim T, Wenaweser P, Togni M, Cook S, Heg D, Windecker S, Goy JJ, Stortecky S. Age-Related Outcomes After Transcatheter Aortic Valve Replacement: Insights From the SwissTAVI Registry. JACC Cardiovasc Interv. 2021 May 10;14(9):952-960. doi: 10.1016/j.jcin.2021.01.042. Epub 2021 Apr 14.
Reference Type
DERIVED
Okuno T, Corpataux N, Spano G, Grani C, Heg D, Brugger N, Lanz J, Praz F, Stortecky S, Siontis GCM, Windecker S, Pilgrim T. True-severe stenosis in paradoxical low-flow low-gradient aortic stenosis: outcomes after transcatheter aortic valve replacement. Eur Heart J Qual Care Clin Outcomes. 2021 Jul 21;7(4):366-377. doi: 10.1093/ehjqcco/qcab010.
Reference Type
DERIVED
Sweda R, Dobner S, Heg D, Lanz J, Malebranche D, Langhammer B, Okuno T, Praz F, Raber L, Valgimigli M, Reineke D, Pilgrim T, Windecker S, Stortecky S. Discharge Location and Outcomes After Transcatheter Aortic Valve Implantation. Am J Cardiol. 2021 Feb 1;140:95-102. doi: 10.1016/j.amjcard.2020.10.058. Epub 2020 Nov 2.
Reference Type
DERIVED
Okuno T, Brugger N, Asami M, Heg D, Siontis GCM, Winkel MG, Lanz J, Grani C, Huber A, Stortecky S, George I, Kodali S, Pilgrim T, Windecker S, Khalique OK, Praz F. Clinical impact of mitral calcium volume in patients undergoing transcatheter aortic valve implantation. J Cardiovasc Comput Tomogr. 2021 Jul-Aug;15(4):356-365. doi: 10.1016/j.jcct.2020.10.003. Epub 2020 Oct 21.
Reference Type
DERIVED
Okuno T, Hagemeyer D, Brugger N, Ryffel C, Heg D, Lanz J, Praz F, Stortecky S, Raber L, Roten L, Reichlin T, Windecker S, Pilgrim T. Valvular and Nonvalvular Atrial Fibrillation in Patients Undergoing Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Sep 28;13(18):2124-2133. doi: 10.1016/j.jcin.2020.05.049.
Reference Type
DERIVED
Okuno T, Asami M, Heg D, Lanz J, Praz F, Hagemeyer D, Brugger N, Grani C, Huber A, Spirito A, Raber L, Stortecky S, Windecker S, Pilgrim T. Impact of Left Ventricular Outflow Tract Calcification on Procedural Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Interv. 2020 Aug 10;13(15):1789-1799. doi: 10.1016/j.jcin.2020.04.015.
Reference Type
DERIVED
Stortecky S, Heg D, Tueller D, Pilgrim T, Muller O, Noble S, Jeger R, Toggweiler S, Ferrari E, Taramasso M, Maisano F, Hoeller R, Wenaweser P, Nietlispach F, Widmer A, Huber C, Roffi M, Carrel T, Windecker S, Conen A. Infective Endocarditis After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2020 Jun 23;75(24):3020-3030. doi: 10.1016/j.jacc.2020.04.044.
Reference Type
DERIVED
Muller O, Fournier S, Pilgrim T, Heg D, Noble S, Jeger R, Toggweiler S, Taramasso M, Windecker S, Stortecky S; SwissTAVI Investigators. Local Versus General Anesthesia for Transcatheter Aortic Valve Replacement: A SwissTAVI Registry Analysis. JACC Cardiovasc Interv. 2019 Sep 23;12(18):1874-1876. doi: 10.1016/j.jcin.2019.05.047. No abstract available.
Reference Type
DERIVED
Baumann F, Obeid S, Gilhofer T, Siegrist P, von Spiczak J, Luscher TF, Binder RK. Right coronary artery motion analysis: a novel method to measure right ventricular systolic function by selective coronary angiography. Int J Cardiovasc Imaging. 2019 Sep;35(9):1557-1561. doi: 10.1007/s10554-019-01606-9. Epub 2019 May 2.
Reference Type
DERIVED
Asami M, Pilgrim T, Lanz J, Heg D, Franzone A, Piccolo R, Langhammer B, Praz F, Raber L, Valgimigli M, Roost E, Windecker S, Stortecky S. Prognostic Relevance of Left Ventricular Myocardial Performance After Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2019 Jan;12(1):e006612. doi: 10.1161/CIRCINTERVENTIONS.118.006612.
Reference Type
DERIVED
Asami M, Stortecky S, Praz F, Lanz J, Raber L, Franzone A, Piccolo R, Siontis GCM, Heg D, Valgimigli M, Wenaweser P, Roost E, Windecker S, Pilgrim T. Prognostic Value of Right Ventricular Dysfunction on Clinical Outcomes After Transcatheter Aortic Valve Replacement. JACC Cardiovasc Imaging. 2019 Apr;12(4):577-587. doi: 10.1016/j.jcmg.2017.12.015. Epub 2018 Feb 14.
Reference Type
DERIVED
Binder RK, Stortecky S, Heg D, Tueller D, Jeger R, Toggweiler S, Pedrazzini G, Amann FW, Ferrari E, Noble S, Nietlispach F, Maisano F, Raber L, Roffi M, Grunenfelder J, Juni P, Huber C, Windecker S, Wenaweser P. Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves. Circ Cardiovasc Interv. 2015 Oct;8(10):e002653. doi: 10.1161/CIRCINTERVENTIONS.115.002653.
Reference Type
DERIVED
Wenaweser P, Stortecky S, Heg D, Tueller D, Nietlispach F, Falk V, Pedrazzini G, Jeger R, Reuthebuch O, Carrel T, Raber L, Amann FW, Ferrari E, Toggweiler S, Noble S, Roffi M, Gruenenfelder J, Juni P, Windecker S, Huber C. Short-term clinical outcomes among patients undergoing transcatheter aortic valve implantation in Switzerland: the Swiss TAVI registry. EuroIntervention. 2014 Dec;10(8):982-9. doi: 10.4244/EIJV10I8A166.
Reference Type
DERIVED
Other Identifiers
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056/11
Identifier Type: -
Identifier Source: org_study_id
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