Anesthesia for Catheter Aortic Valve ImplantATIOn Registry

Heart Failure Clinical Trial

— AVIATOR  

Official title:

Anesthesia for Catheter Aortic Valve ImplantATIOn Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01390675
• Other study ID #: GE DHM-AN-OR-2011/04
• Secondary ID: GE DHM-AN-OR-201
• Status: Recruiting
• Start date: June 2011
• Est. completion date: December 2027

Study information

• Verified date: June 2023
• Source: Deutsches Herzzentrum Muenchen
• Contact: Patrick N Mayr, M.D.
• Phone: +49 89 1218
• Email: mayrp[@]dhm.mhn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In modern cardiac surgery and cardiology Transcatheter Aortic Valve Implantation (TAVI) is an emerging procedure for high-risk patients that are assumed to be otherwise inoperable. The investigators want to evaluate the specific intraoperative anesthesiologic characteristics cardiac anesthesiologists have to face during these procedures.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion Criteria:

• Refusal by patient

Related Conditions & MeSH terms

• Anesthesia
• Critical Incident
• Excessive Amount of Blood / Fluid Transfusion
• Failed Conscious Sedation During Procedure
• Heart Arrest
• Heart Failure
• Intraoperative Cardiac Arrest During Cardiac Surgery

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perioperative Care	major critical adverse events	1 day
Secondary	Up to 10 years	all-cause mortality	10 Years