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OpenTrials
Completed

NCT Number: NCT01251328

Near INfrared Spectroscopy in Aortic valvE ReplacemenT

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Eligibility for Both Anaesthetic Methods Heart Diseases Heart Valve Diseases Transcatheter Aortic Valve Implantation Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum München

Munich, Bavaria, D-80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • informed consent
  • transcatheter aortic valve implantation

Exclusion criteria

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

Treatment and study plan

General anaesthesia

Procedure

general anaesthesia is performed according to the hospitals standard

Sedation

Procedure

Sedation is performed according to the hospitals standard

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Acronym: INSERT

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Dec 1, 2010
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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