Near INfrared Spectroscopy in Aortic valvE ReplacemenT

Aortic Valve Stenosis Clinical Trial

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Official title:

Near Infrared Spectroscopy in Aortic Valve Replacement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251328
• Other study ID #: GE DHM-AN-OR-2010/01
• Status: Completed
• Phase: N/A
• First received: November 29, 2010
• Last updated: February 9, 2015
• Start date: December 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2015
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics comittee,Technische Universität München
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• informed consent

• transcatheter aortic valve implantation

Exclusion Criteria:

• denial by patient

• denial by screening anaesthesist

• active neurodegenerative disease

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Eligibility for Both Anaesthetic Methods
• Transcatheter Aortic Valve Implantation

Intervention

Procedure:
• General anaesthesia
general anaesthesia is performed according to the hospitals standard
• Sedation
Sedation is performed according to the hospitals standard

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum München	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral oxygen desaturation during the "rapid pacing" period and periprocedural	Biomarkers for cerebral ischemia will be measured up to 48 hours	up to 48 hours	Yes