Heart FailureAVIATORNCT01390675
Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
An observational study of Heart Failure and Excessive Amount of Blood / Fluid Transfusion, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Excessive Amount of Blood / Fluid Transfusion, Intraoperative Cardiac Arrest During Cardiac Surgery
- How many people
- 10,000 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2011to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing transcatheter aortic valve implantation (TAVI)
Who may be able to join
- Patients undergoing transcatheter aortic valve implantation (TAVI)
Who cannot join
- Refusal by patient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München
Munich, Bavaria, D-80636
About this study
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.
- Conditions
- Heart Failure, Excessive Amount of Blood / Fluid Transfusion, Intraoperative Cardiac Arrest During Cardiac Surgery, Critical Incident, Anesthesia, Failed Conscious Sedation During Procedure
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative Care
major critical adverse events
Measured: 1 day
Secondary outcomes (1)
Up to 10 years
all-cause mortality
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, N Patrick Mayr, Deutsches Herzzentrum Muenchen
- Investigators
- Patrick N Mayr, M.D., Principal investigator, Deutsches Herzzentrum München, Technische Universität MünchenMichael Joner, MD, Prof., Principal investigator, Deutsches Herzzentrum München, Technische Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390675
- Sponsor's protocol ID
- GE DHM-AN-OR-2011/04
- Other IDs
- GE DHM-AN-OR-2011/04
- Acronym
- AVIATOR
- Status last verified
- Aug 2024
- First submitted
- 27 Jun 2011
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesia for Catheter Aortic Valve ImplantATIOn Registry
- ClinicalTrials.gov ID
- NCT01390675
- Acronym / sponsor ID
- AVIATOR / GE DHM-AN-OR-2011/04
- Conditions
- Heart Failure, Excessive Amount of Blood / Fluid Transfusion, Intraoperative Cardiac Arrest During Cardiac Surgery, Critical Incident, Anesthesia, Failed Conscious Sedation During Procedure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transcatheter aortic valve implantation (TAVI)
Key inclusion criteria (1 listed)
- Patients undergoing transcatheter aortic valve implantation (TAVI)
Key exclusion criteria (1 listed)
- Refusal by patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative Care
Time frame: 1 day
major critical adverse events
1 secondary outcome
Up to 10 years
Time frame: 10 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Derived from this study: PubMed 29464420Mayr 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Excessive Amount of Blood / Fluid Transfusion, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick N Mayr, M.D. (+49 89 1218 ext. 0, mayrp@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative Care (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01390675, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.