Leaflet abnormalities following surgical, bioprosthetic mitral valve replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00014758

Enrollment

500

Registered

2018-12-07

Start date

2019-01-14

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Z95.2 T82.8

Interventions

Group 1: This study uses CT-scans, echocardiography, and blood work to investigate leaflet abnormalities following surgical bioprosthetic mitral valve replacement (sMVR) at Heart Center Leipzig. This

reduced leaflet motion

hypo-attenuation affecting motion) • Echocardiography: leaflet thickening >2mm, mean transvalvular gradient, doppler velocity index, effective orifice area • Supra-ventricular rhythm disturbances • An

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: surgical, bioprosthetic mitral valve replacement between January, 1st 2008 and December 31st 2017

Exclusion criteria

Exclusion criteria: * female patients with chilbearing potential (period within the past two years) * known allergy against iodine, iodinie-containing contrast agents, or beta-blocker * latente or manifest hyperthyreoidism, nodular thyroid disease, Graves' disease * renal insufficciency (GFR <45l/min/1.73m2)

Design outcomes

Primary

Measure	Time frame
a) leaflet thickening together with changes in contrast (hypoattenuated leaflet thickening (HALT), evaluated in long and short axis as reduced leaflet contour and -contrast; b) reduced leaflet motion and/or opening (RELM, hypoattenuation affecting motion, HAM), evaluated as maximum valve opening from the the view that directly faces the prosthesis in volume rendered images, by measuring from the inner margin of the stent frame to the margin of the affected leaflet tip and presenting as the relation between this distance and the maximum distance from the center of the prosthesis to stent frame. The categorization is made as mildly reduced (70%) motion. Reduced leaflet motion of moderat or more is considered clinically relevant and defined as HAM. All mentioned variables are acquired during a single follow-up visit.	—

Measure

Time frame

a) leaflet thickening together with changes in contrast (hypoattenuated leaflet thickening (HALT), evaluated in long and short axis as reduced leaflet contour and -contrast; b) reduced leaflet motion and/or opening (RELM, hypoattenuation affecting motion, HAM), evaluated as maximum valve opening from the the view that directly faces the prosthesis in volume rendered images, by measuring from the inner margin of the stent frame to the margin of the affected leaflet tip and presenting as the relation between this distance and the maximum distance from the center of the prosthesis to stent frame. The categorization is made as mildly reduced (70%) motion. Reduced leaflet motion of moderat or more is considered clinically relevant and defined as HAM. All mentioned variables are acquired during a single follow-up visit.

—

Secondary

Measure	Time frame
The secondary measures are collected during a singe follow-up visit, i.e. on the same day as the CT scan. (1) sensitivity and specificity of echocardiography and blood work, and its association with CT; (2) influence of comorbidities (cardiac; non-cardiac; malignancy); (3) influence of medication, in particular with respect to plateled inhibitors and anticoagulation (vitamin-K-antagonists, platelet inhibitors, novel oral anticoagulants); (4) influence of surgical and peri-procedural parameters (indication for surgery, time since surgery, surgical access, size and model of bioprosthesis used) The secondary endpoints are measured using statistical methods following completion of data acquisition.	—

Measure

Time frame

The secondary measures are collected during a singe follow-up visit, i.e. on the same day as the CT scan. (1) sensitivity and specificity of echocardiography and blood work, and its association with CT; (2) influence of comorbidities (cardiac; non-cardiac; malignancy); (3) influence of medication, in particular with respect to plateled inhibitors and anticoagulation (vitamin-K-antagonists, platelet inhibitors, novel oral anticoagulants); (4) influence of surgical and peri-procedural parameters (indication for surgery, time since surgery, surgical access, size and model of bioprosthesis used) The secondary endpoints are measured using statistical methods following completion of data acquisition.

—

Countries

Germany, United States

Contacts

Public ContactMichael Borger

Herzzentrum Leipzig, Universitätsklinik für Herzchirurgie

Michael.Borger@helios-gesundheit.de0341 865 - 1423

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026