Everyday Practice With Transcatheter Aortic Valve Implantation

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: aortic valve prostheses

• Registration Number: NCT02289339
• Lead Sponsor: LMU Klinikum

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.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2014-11-08
• Study First Submitted QC: 2014-11-12
• Study First Posted: 2014-11-13
• Primary Completion: 2018-04-20
• Study Completion: 2018-05-20
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2370

Inclusion Criteria

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

Exclusion Criteria

• Contraindication to transfemoral TAVI procedure

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TAVI patients	aortic valve prostheses	all patients undergoing transcatheter aortic valve prostheses implantation

Primary Outcome Measures

Name	Time	Method
incidence of post-TAVI aortic regurgitation	30 days	echocardiographicall and angiographycally determined

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Cardiology Department, Segeberger Kliniken; 🇩🇪 Bad Segeberg, Germany

Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University; 🇩🇪 Munich, Germany