NCT01390675

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
19mo left

Started Jun 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jun 2011Dec 2027

Study Start

First participant enrolled

June 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
15.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

August 7, 2024

Status Verified

August 1, 2024

Enrollment Period

15.5 years

First QC Date

June 27, 2011

Last Update Submit

August 5, 2024

Conditions

Heart FailureExcessive Amount of Blood / Fluid TransfusionIntraoperative Cardiac Arrest During Cardiac SurgeryCritical IncidentAnesthesiaFailed Conscious Sedation During Procedure

Outcome Measures

Primary Outcomes (1)

  • Perioperative Care

    major critical adverse events

    1 day

Secondary Outcomes (1)

  • Up to 10 years

    10 Years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing transcatheter aortic valve implantation (TAVI)

You may qualify if:

  • \- Patients undergoing transcatheter aortic valve implantation (TAVI)

You may not qualify if:

  • \- Refusal by patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München

Munich, Bavaria, D-80636, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 29464420DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Patrick N Mayr, M.D.

    Deutsches Herzzentrum München, Technische Universität München

    PRINCIPAL INVESTIGATOR

  • Michael Joner, MD, Prof.

    Deutsches Herzzentrum München, Technische Universität München

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick N Mayr, M.D.

CONTACT

+49 89 1218mayrp@dhm.mhn.de

Michael Joner, M.D.,Prof

CONTACT

+49 89 1218joner@dhm.mhn.de

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 11, 2011

Study Start

June 1, 2011

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

August 7, 2024

Record last verified: 2024-08

Locations

DE(1)