Clinical studies / registries

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We design, run, and publish data from clinical registries, either independently or with partners in the healthcare sector. We currently work in collaboration with a large number of European hospitals.

Registries are initiated by interested clinicians or by relevant companies. We start with a project idea, from which we formulate a registry protocol and electronic questionnaire. The results are then jointly published by the participating centres.

These registries are generally financed by an external funding source, while we assume overall responsibility for project implementation (“Sponsorship”). For this, we work with established experts in the relevant fields, ensuring successful planning and implementation.

ROUTE

Multicentre European quality assurance registry of transaortic TAVI procedures.

NCT01991431 https://clinicaltrials.gov/ct2/show/NCT01991431

Bramlage P, Romano M, Bonaros N, Cocchieri R, Jagielak D, Frank D, Bapat V. Transaortic transcatheter aortic valve implantation – rationale and design of the multicenter, multinational prospective ROUTE registry. BMC Cardiovasc Disord. 2014 Nov 1;14:152.

Bapat V, Frank D, Cocchieri R, Jagielak D, Bonaros N, Aiello M, Lapeze J, Laine M, Chocron S, Muir D, Eichinger W, Thielmann M, Labrousse L, Rein KA, Verhoye JP, Gerosa G, Baumbach H, Bramlage P, Deutsch C, Thoenes M, Romano M. Transcatheter aortic valve implantation using transaortic access – experience from the multicentre, multinational, prospective ROUTE registry. JACC CI 2016.

Jagielak D, Bramlage P, Pawlaczyk R, Brzeziński M, Fijałkowski M, Łaskawski G, Ciećwierz D, Rogowski J, Kozaryn R. Transaortic transcatheter aortic valve implantation: Results of the Polish arm of the ROUTE registry. Cardiol J 2015; 22: 651-656.

CGA-TAVI

Multicentre Global registry on the importance of carrying out a geriatric assessment prior to performing TAVI.

NCT01991444 https://clinicaltrials.gov/ct2/show/NCT01991444

Schönenberger AW, Werner N, Bramlage P, Martinez-Selles M, Maggi S, Bauernschmitt R, Thoenes M, Kurucova J, Michel JP, Ungar A. Comprehensive geriatric assessment in patients undergoing transcatheter aortic valve implantation–rationale and design of the European CGA-TAVI registry. Eur Ger Med 2014, 5: 8-13.

EASE-IT TA

Multicentre German registry on the need for BAV prior to TA-TAVI.

NCT02127580 https://clinicaltrials.gov/ct2/show/NCT02127580

Bramlage P, Strauch J, Schröfel H. Balloon expandable transcatheter aortic valve implantation with or without pre-dilation of the aortic valve – rationale and design of a multicenter registry (EASE-IT). BMC Cardiovasc Disord. 2014 Nov 18;14:160.

EASE-IT TF

Multicentre German registry on the need for BAV prior to TF-TAVI.

NCT02760771 https://clinicaltrials.gov/ct2/show/NCT02760771

Butter C, Bramlage P, Rudolph T, Jacobshagen C, Rothe J, Treede H, Kerber S, Frank D, Seilerova L, Schymik G. Balloon expandable transcatheter aortic valve implantation via the transfemoral route with or without pre-dilation of the aortic valve – rationale and design of a multicenter registry (EASE-IT TF). BMC Cardiovasc Disord. 2016 Nov 15;16:223.

DIVE

Multicentre German registry for Quality assurance in the care of patients with diabetes.

www.dive-register.de

Bramlage P, Lanzinger S, Rathmann W, Gillessen A, Scheper N, Schmid SM, Kaltheuner M, Seufert J, Danne T, Holl RW. Dyslipidaemia and its treatment in patients with type 2 diabetes – a joint analysis of the German DIVE and DPV registries. Diabetes Obes Metab. 2016.

Bramlage P, Bluhmki T, Rathmann W, Kaltheuner M, Beyersmann J, Danne T; DIVE study group. Identifying patients with type 2 diabetes in which basal supported oral therapy may not be the optimal treatment strategy. Diabetes Res Clin Pract. 2016;116:127-35.

Danne T, Bluhmki T, Seufert J, Kaltheuner M, Rathmann W, Beyersmann J, Bramlage P; DIVE study group. Treatment intensification using long-acting insulin -predictors of future basal insulin supported oral therapy in the DIVE registry. BMC Endocr Disord. 2015;15:54.

Bluhmki T, Bramlage P, Volk M, Kaltheuner M, Danne T, Rathmann W, Beyersamnn J. Methodological challences and time-toevent techniques in register-based heatlh Services research. J Clin Epidemiol 2016.

Danne T, Kaltheuner M, Koch A, Ernst S, Rathmann W, Rüssmann HJ, Bramlage P; DIVE Studiengruppe. [“DIabetes Versorgungs-Evaluation” (DIVE)–a national quality assurance initiative at physicians providing care for patients with diabetes]. Dtsch Med Wochenschr. 2013;138:934-9.

Contact person

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Prof. Dr. med. Peter Bramlage
Tel.: +49 3379-314 78 90
email: peter.bramlage(at)ippmed.de