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RecruitingNCT01390675AVIATORUpdated Aug 7, 2024

Anesthesia for Catheter Aortic Valve ImplantATIOn Registry

An observational study in Heart Failure, Excessive Amount of Blood / Fluid Transfusion and Intraoperative Cardiac Arrest During Cardiac Surgery, sponsored by Deutsches Herzzentrum Muenchen. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-07.

Sponsored by Deutsches Herzzentrum Muenchen · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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

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In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.

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Lead sponsor

Deutsches Herzzentrum Muenchen is the lead sponsor of 114 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients undergoing transcatheter aortic valve implantation (TAVI)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing transcatheter aortic valve implantation (TAVI)

Exclusion criteria

Exclusion Criteria:

  • Refusal by patient
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
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What researchers measure

Primary outcomes

  1. Perioperative Care

    major critical adverse events

    Time frame: 1 day

Secondary outcomes

  1. Up to 10 years

    all-cause mortality

    Time frame: 10 Years

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Study locations

1 of 1 sites recruiting
  • Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
    Munich, Bavaria D-80636, Germany
    Recruiting
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References and documents

Publications

  • Mayr NP, Wiesner G, van der Starre P, Hapfelmeier A, Goppel G, Kasel AM, Hengstenberg C, Husser O, Schunkert H, Tassani-Prell P. Dexmedetomidine versus propofol-opioid for sedation in transcatheter aortic valve implantation patients: a retrospective analysis of periprocedural gas exchange and hemodynamic support. Can J Anaesth. 2018 Jun;65(6):647-657. doi: 10.1007/s12630-018-1092-4. Epub 2018 Feb 20. PubMed 29464420 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01390675
Responsible party
N Patrick Mayr (MD, Deutsches Herzzentrum Muenchen) — Principal investigator
First posted
Jul 11, 2011
Start date
Jun 2011
Primary completion
Dec 2026 (estimated)
Completion
Dec 2027 (estimated)
Last update
Aug 7, 2024

Study contacts

Patrick N Mayr, M.D.
Contact
mayrp@dhm.mhn.de
+49 89 1218 ext. 0
Michael Joner, M.D.,Prof
Contact
joner@dhm.mhn.de
+49 89 1218 ext. 0
Patrick N Mayr, M.D.
principal investigator · Deutsches Herzzentrum München, Technische Universität München
Michael Joner, MD, Prof.
principal investigator · Deutsches Herzzentrum München, Technische Universität München

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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