Clinical trial NCT01368250: SwissTAVI Registry
Official title: SwissTAVI Registry: Prospective, National, Multi-Center Registry of Patients Undergoing Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Disease Mixed
Keywords: Aortic valve
Heart valve
VARC
Transcatheter
Minimal-invasive
TAVI
TAVR
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Native aortic valve stenosis
* 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

Primary outcomes:
measure: combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
timeFrame: 1 year
Secondary outcomes:
measure: combined early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
timeFrame: 30days
measure: combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
timeFrame: 5 years
measure: combined safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)
timeFrame: 10 years , 15 years
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Cardiology
city: Bern
country: Switzerland
facility: Department of Cardiology
Study officials:
affiliation: Bern University Hospital
name: Stefan Stortecky, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.