Near INfrared Spectroscopy in Aortic valvE ReplacemenT (INSERT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01251328
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : February 10, 2015
Information provided by (Responsible Party):
N Patrick Mayr, Deutsches Herzzentrum Muenchen

Brief Summary:

Transcatheter aortic valve implantation (TAVI) is an alternative for patients, that are considered to be too sick for conventional aortic valve replacement. There is no conclusive opinion about the best anesthesiologic management of these patients. Sedation and general anaesthesia are both adequate and the current literature shows no benefit towards one of these methods.

This study wants to investigate the influence of these two anesthesiologic managements on the cerebral oxygen saturation during the "rapid pacing"-period during valvuloplasty. The patients are randomised allocated to one of these two anaesthesiological managements. The investigators use the Near-Infrared Spectroscopy (NIRS) to measure the cerebral oxygen saturation. Parallel there will be a measurement of cerebral biomarkers to monitor cerebral hypoxia.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Eligibility for Both Anaesthetic Methods Procedure: General anaesthesia Procedure: Sedation Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Near Infrared Spectroscopy in Aortic Valve Replacement
Study Start Date : December 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

Arm Intervention/treatment
Active Comparator: General anaesthesia
General anaesthesia is performed under standardized conditions
Procedure: General anaesthesia
general anaesthesia is performed according to the hospitals standard

Active Comparator: Sedation
Sedation is performed under standardized conditions
Procedure: Sedation
Sedation is performed according to the hospitals standard

Primary Outcome Measures :
  1. Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural [ Time Frame: up to 48 hours ]
    Biomarkers for cerebral ischemia will be measured up to 48 hours

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • informed consent
  • transcatheter aortic valve implantation

Exclusion Criteria:

  • denial by patient
  • denial by screening anaesthesist
  • active neurodegenerative disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01251328

Deutsches Herzzentrum München
Munich, Bavaria, Germany, D-80636
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Principal Investigator: Patrick N Mayr, MD Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: N Patrick Mayr, MD, Deutsches Herzzentrum Muenchen Identifier: NCT01251328     History of Changes
Other Study ID Numbers: GE DHM-AN-OR-2010/01
First Posted: December 1, 2010    Key Record Dates
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Central Nervous System Depressants
Physiological Effects of Drugs