Everyday Practice With Transcatheter Aortic Valve Implantation

NCT02289339 | Completed

• 1 other identifier: MucS001-14
• Study Type: observational
• Target: 2,370
• Locations: 1 country
• Sites: 2

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.

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• incidence of post-TAVI aortic regurgitation

  echocardiographicall and angiographycally determined

  30 days

Secondary Outcomes (9)

• incidence of bleeding complications

  30 days

• mortality

  30 days

• mortality rate

  2-years

• mortality rate

  5-years

• incidence of cerebrovascular events

  30 days

Other Outcomes (3)

• incidence of vascular complications

  30 days

• incidence of re-hospitalisation

  2-year

• incidence of re-hospitalisation

  5-year

Study Arms (1)

TAVI patients

all patients undergoing transcatheter aortic valve prostheses implantation

Device: aortic valve prostheses

Interventions

aortic valve prostheses DEVICE

balloon-expandable and self-expandable aortic valve prostheses

Also known as: CoreValve, CoreValveE, Sapien XT, Sapien S3, Lotus

TAVI patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Contraindication to transfemoral TAVI procedure

Sponsors & Collaborators

• LMU Klinikum: lead

Study Sites (2)

Cardiology Department, Segeberger Kliniken

Bad Segeberg, Germany

Location

Department of Cardiology, Munich University Clinic, Ludwig-Maximilian University

Munich, Germany

Location

Related Publications (6)

• 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.

  PMID: 28784441 RESULT

• 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.

  PMID: 27866140 RESULT

• 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.

  PMID: 27038099 RESULT

• 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.

  PMID: 26093840 RESULT

• 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.

  PMID: 25812583 RESULT

• 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.

  PMID: 25017451 RESULT

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Julinda Mehilli, Prof. MD

  Cardiology Department, Munich University Clinic, Ludwig-Maximilian University

  PRINCIPAL INVESTIGATOR

• Steffen Massberg, Prof. MD

  Cardiology Department, Munich University Clinic, Ludwig-Maximilian University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: November 8, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2007
• Primary Completion: April 20, 2018
• Study Completion: May 20, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

DE (2)