Near INfrared Spectroscopy in Aortic valvE ReplacemenT (INSERT)

This study has been completed.

Sponsor:

Information provided by:

Deutsches Herzzentrum Muenchen

ClinicalTrials.gov Identifier:

NCT01251328

First received: November 29, 2010

Last updated: April 27, 2012

Last verified: April 2012

History of Changes

Purpose

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	Intervention
Aortic Valve Stenosis Transcatheter Aortic Valve Implantation Eligibility for Both Anaesthetic Methods	Procedure: General anaesthesia Procedure: Sedation

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Near Infrared Spectroscopy in Aortic Valve Replacement

Resource links provided by NLM:

Genetics Home Reference related topics: supravalvular aortic stenosis

MedlinePlus related topics: Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:

Cerebral oxygen desaturation during the "rapid pacing" period [ Time Frame: up to 48 hours ] [ Designated as safety issue: Yes ]
Biomarkers for cerebral ischemia will be measured up to 48 hours

Estimated Enrollment:	66
Study Start Date:	December 2010
Study Completion Date:	April 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

informed consent
transcatheter aortic valve implantation

Exclusion Criteria:

denial by patient
denial by screening anaesthesist
active neurodegenerative disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251328

Locations

Germany
Deutsches Herzzentrum München
Munich, Bavaria, Germany, D-80636

Sponsors and Collaborators

Deutsches Herzzentrum Muenchen

Investigators

Principal Investigator:

Patrick N Mayr, MD

Deutsches Herzzentrum München, Department of Anaesthesiology, Technische Universität München

More Information

No publications provided

Responsible Party:	N. Patrick Mayr, MD and P. Tassani, MD, PhD, Deutsches Herzzentrum München
ClinicalTrials.gov Identifier:	NCT01251328 History of Changes
Other Study ID Numbers:	GE DHM-AN-OR-2010/01
Study First Received:	November 29, 2010
Last Updated:	April 27, 2012
Health Authority:	Germany: Ethics comittee,Technische Universität München

Additional relevant MeSH terms:

Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Anesthetics

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2013

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