NCT05736289

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

February 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

2.4 years

First QC Date

February 9, 2023

Last Update Submit

July 21, 2023

Conditions

Mitral RegurgitationMitral Valve DiseaseMitral Valve Insufficiency

Outcome Measures

Primary Outcomes (1)

  • Arterial pressure waveform changes

    Arterial pressure waveform as recorded by a continuous non invasive hemodynamic monitoring system.

    Before and during general anesthesia for mitral valve repair or replacement, ranging from 1 to 5 hours.

Study Arms (2)

Percutaneous mitral valve repair

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

Surgical mitral valve repair or replacement

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with moderate or severe mitral valve insufficiency undergoing cardiothoracic surgery or percutaneous treatment for their mitral valve condition.

You may qualify if:

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

You may not qualify if:

  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center

Amsterdam, 1105AZ, Netherlands

RECRUITING

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Denise P Veelo, MD PhD

    Amsterdam University Medical Center - University of Amsterdam

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan TM Tol, MD

CONTACT

020 566 6478j.tol2@amsterdamumc.nl

Denise P Veelo, MD PhD

CONTACT

020 566 6478d.p.veelo@amsterdamumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

February 9, 2023

First Posted

February 21, 2023

Study Start

February 13, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

NL(1)