Everyday Practice With Transcatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

— EVERY-TAVI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289339
• Other study ID #: MucS001-14
• Status: Completed
• Start date: November 2007
• Est. completion date: May 20, 2018

Study information

• Verified date: August 2018
• Source: Klinikum der Universitaet Muenchen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2370
• Est. completion date: May 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Aortic stenosis

• Intermediate-to-high risk for surgery

• Heart team decision

Exclusion Criteria:

• Contraindication to transfemoral TAVI procedure

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• aortic valve prostheses
balloon-expandable and self-expandable aortic valve prostheses

Locations

Country	Name	City	State
Germany	Cardiology Department, Segeberger Kliniken	Bad Segeberg
Germany	Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum der Universitaet Muenchen

Country where clinical trial is conducted

Germany, 

References & Publications (6)

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. — View Citation

Jochheim D, Abdel-Wahab M, Mehilli J, Ellert J, Wübken-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. Mine — View Citation

Jochheim D, Schneider VS, Schwarz F, Kupatt C, Lange P, Reiser M, Massberg S, Gutiérrez-Chico JL, Mehilli J, Becker HC. Contrast-induced acute kidney injury after computed tomography prior to transcatheter aortic valve implantation. Clin Radiol. 2014 Oct; — View 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 implanta — View 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 — View 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 sutur — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of vascular complications	defined according to VARC-2 classification	30 days
Other	incidence of re-hospitalisation	new unplanned hospital stay due to cardiovascular und cerebrovascular reasons	2-year
Other	incidence of re-hospitalisation	new unplanned hospital stay due to cardiovascular und cerebrovascular reasons	5-year
Primary	incidence of post-TAVI aortic regurgitation	echocardiographicall and angiographycally determined	30 days
Secondary	incidence of bleeding complications	defined according to BARC and VARC-2 classification	30 days
Secondary	mortality	all-cause and cardio/cerebrovascular death	30 days
Secondary	mortality rate	all-cause and cardio/cerebrovascular death	2-years
Secondary	mortality rate	all-cause and cardio/cerebrovascular death	5-years
Secondary	incidence of cerebrovascular events	stroke or TIA	30 days
Secondary	incidence of cerebrovascular events	stroke or TIA	2-years
Secondary	incidence of cerebrovascular events	stroke or TIA	5-years
Secondary	incidence of new pacemaker implantation	pacemaker after TAVI	30-day
Secondary	incidence of new pacemaker implantation	pacemaker after TAVI	1-year