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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Anesthetics
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014