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3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation

3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04442828
Acronym
3D-PRIME
Enrollment
300
Registered
2020-06-23
Start date
2020-04-17
Completion date
2025-04-30
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitral Regurgitation

Brief summary

The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.

Interventions

DIAGNOSTIC_TESTUse of 3D echocardiography in patient follow-up

Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult patients with primary or secondary mitral regurgitation (MR) * MR of moderate or severe degree * 3D echocardiographic examinations of \>= good spatial and temporal resolution

Exclusion criteria

* Co-existence of another valve disease of severe degree * Inability to give informed consent

Design outcomes

Primary

MeasureTime frameDescription
Major cardiovascular event24 monthsDeath, mitral valve intervention, heart failure hospitalization

Secondary

MeasureTime frame
All-cause death24 months
Cardiovascular death24 months
Mitral valve intervention24 months

Countries

Norway

Contacts

Primary ContactDana Cramariuc, MD PhD
cdan@helse-bergen.no+4755976755

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026