SwissTAVI Registry

NCT01368250 | Recruiting DMC

• 1 other identifier: 056/11
• Study Type: observational
• Target: 20,000
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Aortic Valve Disease Mixed

Keywords

Aortic valve; Heart valve; VARC; Transcatheter; Minimal-invasive; TAVI; TAVR

Outcome Measures

Primary Outcomes (1)

• combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

  Composed by: * death * stroke * aortic valve re-intervention * structural valve deterioration * myocardial Infarction

  1 year

Secondary Outcomes (3)

• combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

  30days

• combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

  5 years

• combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)

  10 years , 15 years

Study Arms (3)

1

Patients with native aortic stenosis undergoing TAVI

Procedure: Transcatheter Aortic Valve Implantation

2

Patients with native aortic regurgitation undergoing TAVI

3

Patients with degenerative surgical bioprosthesis undergoing TAV-in-SAV

Interventions

Transcatheter Aortic Valve Implantation PROCEDURE

Minimal Invasive Implantation of a biological prosthesis in Aortic Position

1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with aortic valve disease or degenerated aortic bioprosthesis scheduled to undergo transcatheter aortic valve implantation (TAVI) using commercially available devices with CE approval are eligible for enrollment in the registry. The TAVI procedure can be performed using all available access routes.

You may qualify if:

• Native aortic valve stenosis
• Native aortic valve regurgitation
• Degenerated aortic bioprosthesis requiring treatment

You may not qualify if:

• Patients refuses informed consent to participate in the registry
• Contraindication for TAVI
• High probability of non-adherence to the follow up - requirements

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

Department of Cardiology

Bern, 3010, Switzerland

RECRUITING

Department of Cardiology

Bern, 3010, Switzerland

RECRUITING

Related Publications (43)

• 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. 2026 Feb;292:107279. doi: 10.1016/j.ahj.2025.09.011. Epub 2025 Sep 18.

  PMID: 40975195 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.

  PMID: 40368460 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 Nov 12;111(23):1149-1155. doi: 10.1136/heartjnl-2024-325359.

  PMID: 40348411 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.

  PMID: 40321306 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.

  PMID: 39536846 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.

  PMID: 39387783 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.

  PMID: 39253713 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.

  PMID: 39067618 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.

  PMID: 38811107 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.

  PMID: 38658128 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.

  PMID: 38355269 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.

  PMID: 38151313 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.

  PMID: 37622754 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.

  PMID: 37491693 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.

  PMID: 37210220 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.

  PMID: 36858662 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.

  PMID: 36754691 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.

  PMID: 36453455 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.

  PMID: 36039573 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.

  PMID: 35640019 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.

  PMID: 35351823 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.

  PMID: 35283064 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.

  PMID: 35093281 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.

  PMID: 35066531 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.

  PMID: 34930717 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.

  PMID: 34788603 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.

  PMID: 34600873 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.

  PMID: 34463717 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.

  PMID: 34342499 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.

  PMID: 34086888 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.

  PMID: 33865734 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.

  PMID: 33576388 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.

  PMID: 33144166 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.

  PMID: 33121904 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.

  PMID: 32972574 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.

  PMID: 32763071 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.

  PMID: 32553254 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.

  PMID: 31537296 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.

  PMID: 31044328 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.

  PMID: 30626203 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.

  PMID: 29454762 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.

  PMID: 26453687 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.

  PMID: 24694729 DERIVED

MeSH Terms

Interventions

Transcatheter Aortic Valve Replacement

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Stefan Stortecky, MD

  Bern University Hospital

  STUDY CHAIR

Central Study Contacts

Stefan Stortecky, MD

CONTACT

0041 31 632 83 52; stefan.stortecky@insel.ch

Stephan Windecker, MD

CONTACT

0041 31 632 83 52; stephan.windecker@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2011
• First Posted: June 7, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

CH (2)