Evaluation of Mitral Valve Insufficiency Under General Anesthesia

NCT ID: NCT05736289

Last Updated: 2023-07-24

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

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-13

Study Completion Date

2025-07-01

Brief Summary

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Observational study in adult humans undergoing surgical or cardiological intervention for mitral valve insufficiency. Investigators aim to evaluate hemodynamic changes on an arterial pressure waveform level in patients before and after mitral valve intervention using Nexfin (BMEYE, Amsterdam, the Netherlands) continuous non-invasive hemodynamic monitoring, using finger cuff based technology to register beat-to-beat data

Detailed Description

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Conditions

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Mitral Regurgitation Mitral Valve Disease Mitral Valve Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Percutaneous mitral valve repair

Patients undergoing percutaneous mitral valve repair under general anesthesia for mitral valve regurgitation.

No interventions assigned to this group

Surgical mitral valve repair or replacement

Patients undergoing surgical mitral valve repair or replacement for mitral valve regurgitation.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for this condition
* Adult patients (\>18 years)

Exclusion Criteria

* No informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role lead

Responsible Party

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Denise P. Veelo

Principal Investigator, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denise P Veelo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam University Medical Center - University of Amsterdam

Locations

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Amsterdam University Medical Center

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Johan TM Tol, MD

Role: CONTACT

020 566 6478

Denise P Veelo, MD PhD

Role: CONTACT

020 566 6478

Facility Contacts

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D. P. Veelo, MD PhD

Role: primary

Other Identifiers

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W22_423

Identifier Type: -

Identifier Source: org_study_id

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