Rational and design of EACVI-MMVD study: an international registry on multimodality imaging for mixed and multiple valvular heart disease.
Alexandre Unger, Giulia Elena Mandoli, Danilo Neglia...
https://pubmed.ncbi.nlm.nih.gov/41635678Actively Recruiting
Age: 18Years +
All Genders
ID06235385
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-06-03
1500
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
E
European Association of Cardiovascular Imaging
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying multiple and mixed valvular heart disease (MMVD), which involves combinations of narrowed or leaking heart valves. This observational study aims to find out how common MMVD is among patients evaluated for valvular heart disease and to describe their clinical and imaging features. The study also looks at management approaches and outcomes like mortality and hospitalizations, addressing a key gap in knowledge about MMVD. The study will include patients diagnosed with MMVD through echocardiography at cardiovascular imaging departments worldwide. It is a prospective, multicenter registry involving 174 centers across 35 countries. Patients will be followed for one year, with the possibility of extending follow-up to five years. Baseline evaluations and management decisions will be made by the treating physicians following current guidelines, including options like surgery, transcatheter valve intervention, or medical care. Participants will undergo clinical assessments, imaging tests, and biomarker measurements as determined by their doctors. Follow-up will occur through visits or contact with patients or physicians to collect information on vital status, hospitalizations, strokes, and additional valve procedures. The primary measure is the proportion of MMVD cases among all valvular heart disease patients. Secondary measures include cardiovascular events, mortality, hospital admissions for heart failure, and changes in echocardiographic findings over time.
CONDITIONS
Brief Title
European Association of Cardiovascular Imaging Multiple and Mixed Valvular Disease Study
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient referred to the cardiovascular imaging department
- Diagnosis of multiple and mixed valvular heart disease confirmed by transthoracic echocardiography
- Multiple VHD: at least 2 moderate to severe valvular heart diseases involving 2 or more different valves
- Mixed VHD: at least moderate stenosis and at least moderate regurgitation of a single valve
- Patient consents to use of their data in the study
You will not qualify if you...
- History of prior valve surgery or percutaneous valve intervention unrelated to MMVD
- Acute infective endocarditis at evaluation or history of endocarditis within the last 6 months
- Complex congenital heart diseases
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for cardiovascular imaging assessment
Diagnostic Evaluation
Duration - Up to 6 months recruitment period
Participants undergo cardiovascular imaging and clinical evaluations to confirm diagnosis of multiple and mixed valvular heart disease and to collect baseline clinical, biological, and imaging data.
1 baseline visit (in-person) with possible additional imaging and assessments as part of routine care
Long-term Monitoring
Duration - 1 to 5 years
Participants are followed for up to 1 year (with possible extension to 5 years) to monitor clinical outcomes including cardiovascular events, hospitalizations, and survival status through visits or contact with physicians or participants.
At least 1 follow-up visit or contact per year
Trial Site Locations
Total: 1 location
1
Assistance Publique Hôpitaux de Paris
Paris, Île-de-France Region, France, 75010
Actively Recruiting
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Research Team
T
Théo PEZEL, MD PhD
A
Alexandre UNGER, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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