Stroke Volume Analysis During Aortic Valve Replacement Trial

NCT ID: NCT02156856

Last Updated: 2014-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-31

Brief Summary

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Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.

Detailed Description

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Conditions

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Hemodynamic Monitoring Cardiac Output Cardiac Surgery

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Hemodynamic optimisation

No interventions assigned to this group

No hemodynamic optimisation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* scheduled transcatheter aortic valve implantation
* signed patient consent form
* aged 18 or older by time of surgery
* no participation in other clinical trials

Exclusion Criteria

* pregnant or breast-feeding women
* emergency surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Michael Sander

Univ.-Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Sander, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Charité Universitätsmedizin Berin

Berlin, State of Berlin, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Sander, MD

Role: CONTACT

+4930450531052

Facility Contacts

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Michael Sander, MD

Role: primary

+4930450531052

Other Identifiers

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EA1/060/13

Identifier Type: -

Identifier Source: org_study_id

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