Everyday Practice With Transcatheter Aortic Valve Implantation (EVERY-TAVI)

Experience With Percutaneous Transcatheter Aortic Valve Implantation in Patients With Symptomatic Aortic Valve Disease in Two German Centers

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: aortic valve prostheses

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.

• Study Type: Observational
• Enrollment (Actual): 2370

Contacts and Locations

Study Locations

• Germany
  • Bad Segeberg, Germany
    • Cardiology Department, Segeberger Kliniken
  • Munich, Germany
    • Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with aortic valve stenosis suitable for transfemoral transcatheter aortic valve implanation

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Contraindication to transfemoral TAVI procedure

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TAVI patients; all patients undergoing transcatheter aortic valve prostheses implantation	Device: aortic valve prostheses; balloon-expandable and self-expandable aortic valve prostheses; Other Names: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of post-TAVI aortic regurgitation	echocardiographicall and angiographycally determined	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of bleeding complications	defined according to BARC and VARC-2 classification	30 days
mortality	all-cause and cardio/cerebrovascular death	30 days
mortality rate	all-cause and cardio/cerebrovascular death	2-years
mortality rate	all-cause and cardio/cerebrovascular death	5-years
incidence of cerebrovascular events	stroke or TIA	30 days
incidence of cerebrovascular events	stroke or TIA	2-years
incidence of cerebrovascular events	stroke or TIA	5-years
incidence of new pacemaker implantation	pacemaker after TAVI	30-day
incidence of new pacemaker implantation	pacemaker after TAVI	1-year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of vascular complications	defined according to VARC-2 classification	30 days
incidence of re-hospitalisation	new unplanned hospital stay due to cardiovascular und cerebrovascular reasons	2-year
incidence of re-hospitalisation	new unplanned hospital stay due to cardiovascular und cerebrovascular reasons	5-year

Collaborators and Investigators

• Sponsor: LMU Klinikum
• Investigators: Principal Investigator: Julinda Mehilli, Prof. MD, Cardiology Department, Munich University Clinic, Ludwig-Maximilian University; Study Chair: Steffen Massberg, Prof. MD, Cardiology Department, Munich University Clinic, Ludwig-Maximilian University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2007
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): May 20, 2018

Study Registration Dates

• First Submitted: November 8, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: MucS001-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No