Evaluating heart valve function during surgery
Evaluation of Mitral Valve Insufficiency Under General Anesthesia
This study is testing a new device to see how well it can monitor heart function in adults with mitral valve problems during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05736289 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients with moderate to severe mitral valve insufficiency who are undergoing surgical or cardiological interventions. The researchers will assess hemodynamic changes by monitoring arterial pressure waveforms before and after the intervention using a non-invasive device called Nexfin. This technology allows for continuous, beat-to-beat data collection through a finger cuff, providing insights into the cardiovascular status of patients during treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with moderate or severe mitral valve insufficiency scheduled for cardiothoracic surgery or percutaneous treatment.
Not a fit: Patients who cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of hemodynamic changes in patients with mitral valve insufficiency, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is observational, similar studies using non-invasive hemodynamic monitoring have shown promise in enhancing patient management during cardiac procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amsterdam
- Amsterdam University Medical Center — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Denise P Veelo, MD PhD — Amsterdam University Medical Center - University of Amsterdam
- Study coordinator: Johan TM Tol, MD
- Email: j.tol2@amsterdamumc.nl
- Phone: 020 566 6478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.