Clinical trial NCT02289339: Everyday Practice With Transcatheter Aortic Valve Implantation
Official title: Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Valve Stenosis
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2014-11-13
Enrollment: 2370
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with aortic valve stenosis suitable for transfemoral transcatheter aortic valve implanation

Brief summary: The purpose of this registry is to document the everyday practice in our centers with minimal invasive treatment of patients with aortic valve disease who were considered suitable for transfemoral aortic valve implantation by heart team.

Detailed description: The TAVI program in our center started on November 2007. As part of the national policy for quality assurance in medicine a detailed clinical characterization of the TAVI-population was required. Furthermore, a detailed description of the procedure and peri-procedural complications until discharge was required. In our center we designed and are routinely using a TAVI database which fulfills the authority requirements as well as has additional data needed for planning and documentation of TAVI procedure. Since there is already a considerable number of TAVI patients in this database we aim to perform statistical analyses answering different question in this filed.

Eligibility criteria: Inclusion Criteria:

* Aortic stenosis
* Intermediate-to-high risk for surgery
* Heart team decision

Exclusion Criteria:

* Contraindication to transfemoral TAVI procedure

Primary outcomes:
measure: incidence of post-TAVI aortic regurgitation
timeFrame: 30 days
Secondary outcomes:
measure: incidence of bleeding complications
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
measure: mortality rate
timeFrame: 2-years
measure: mortality rate
timeFrame: 5-years
measure: incidence of cerebrovascular events
timeFrame: 30 days
measure: incidence of cerebrovascular events
timeFrame: 2-years
measure: incidence of cerebrovascular events
timeFrame: 5-years
measure: incidence of new pacemaker implantation
timeFrame: 30-day
measure: incidence of new pacemaker implantation
timeFrame: 1-year
Other outcomes:
measure: incidence of vascular complications
timeFrame: 30 days
measure: incidence of re-hospitalisation
timeFrame: 2-year
measure: incidence of re-hospitalisation
timeFrame: 5-year
Locations:
city: Bad Segeberg
country: Germany
facility: Cardiology Department, Segeberger Kliniken
city: Munich
country: Germany
facility: Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University
Study officials:
affiliation: Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
name: Julinda Mehilli, Prof. MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cardiology Department, Munich University Clinic, Ludwig-Maximilian University
name: Steffen Massberg, Prof. MD
role: STUDY_CHAIR
References:
citation: Jochheim D, Zadrozny M, Ricard I, Sadry TM, Theiss H, Baquet M, Schwarz F, Bauer A, Khandoga A, Sadoni S, Pichlmaier M, Hausleiter J, Hagl C, Massberg S, Mehilli J. Predictors of cerebrovascular events at mid-term after transcatheter aortic valve implantation - Results from EVERY-TAVI registry. Int J Cardiol. 2017 Oct 1;244:106-111. doi: 10.1016/j.ijcard.2017.03.003.
citation: Mehilli J, Jochheim D, Abdel-Wahab M, Rizas KD, Theiss H, Spenkuch N, Zadrozny M, Baquet M, El-Mawardy M, Sato T, Lange P, Kuppatt C, Greif M, Hausleiter J, Bauer A, Schwarz F, Pichlmaier M, Hagl C, Richardt G, Massberg S. One-year outcomes with two suture-mediated closure devices to achieve access-site haemostasis following transfemoral transcatheter aortic valve implantation. EuroIntervention. 2016 Nov 20;12(10):1298-1304. doi: 10.4244/EIJV12I10A213.
citation: Hein-Rothweiler R, Jochheim D, Rizas K, Egger A, Theiss H, Bauer A, Massberg S, Mehilli J. Aortic annulus to left coronary distance as a predictor for persistent left bundle branch block after TAVI. Catheter Cardiovasc Interv. 2017 Mar 1;89(4):E162-E168. doi: 10.1002/ccd.26503. Epub 2016 Apr 1.
citation: Jochheim D, Zadrozny M, Theiss H, Baquet M, Maimer-Rodrigues F, Bauer A, Lange P, Greif M, Kupatt C, Hausleiter J, Hagl C, Massberg S, Mehilli J. Aortic regurgitation with second versus third-generation balloon-expandable prostheses in patients undergoing transcatheter aortic valve implantation. EuroIntervention. 2015 Jun;11(2):214-20. doi: 10.4244/EIJV11I2A40.
citation: Jochheim D, Abdel-Wahab M, Mehilli J, Ellert J, Wubken-Kleinfeld N, El-Mawardy M, Pache J, Massberg S, Kastrati A, Richardt G. Significant aortic regurgitation after transfemoral aortic valve implantation: patients' gender as independent risk factor. Minerva Cardioangiol. 2015 Oct;63(5):371-9. Epub 2015 Mar 27.
citation: Jochheim D, Schneider VS, Schwarz F, Kupatt C, Lange P, Reiser M, Massberg S, Gutierrez-Chico JL, Mehilli J, Becker HC. Contrast-induced acute kidney injury after computed tomography prior to transcatheter aortic valve implantation. Clin Radiol. 2014 Oct;69(10):1034-8. doi: 10.1016/j.crad.2014.05.106. Epub 2014 Jul 10.