Congestive Heart Failure, Tricuspid Regurgitation
Conditions
Keywords
Heart failure with preserved ejection fraction, tricuspid regurgitation, transcatheter tricuspid valve edge-to-edge repair
Brief summary
The aim of the study is to investigate the pathophysiological implications of transcatheter tricuspid valve edge-to-edge repair in patient with heart failure and preserved ejection fraction and severe tricuspid regurgitation. Changes in right- and left-ventricular function as well as the interventricular dependence will be analysed on a multimodal basis including pressure-volume loop analysis and cardiac magnetic resonance imaging.
Interventions
DEVICETranscatheter tricuspid valve edge-to-edge repair
Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
Sponsors
Heart Center Leipzig - University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
Intervention model description
Patients undergoing transcatheter tricuspid valve edge-to-edge repair will undergo multimodal cardiovascular diagnostics before and after tricuspid valve repair including pressure volume loop analysis and cardiac magnetic resonance imaging
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Severe tricuspid regurgitation with need for interventional treatment approach as decided by an interdisciplinary heart team. * Signs and symptoms of left-sided heart failure. * Left-ventricular ejection fraction ≥50% * Invasive evidence of elevated left-ventricular fillings pressures (pulmonary capillary wedge pressure \[PCWP\] or left-ventricular end-diastolic pressure ≥15 mmHg)
Exclusion criteria
* Concomitant relevant mitral valve regurgitation with need for concomitant interventional treatment * Moderate aortic stenosis. * Pregnancy * Contraindication to perform cardiac magnetic resonance imaging. * Conditions rendering patient unable to give informed consent to the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Periprocedural change in enddiastolic pressure volume relationship of the left ventricle | Periprocedural. | Change in the ratio of pressure to volume of the left ventricle before and after TTVR. Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR) | Periprocedural. | Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software. |
| Change in the ratio of isovolumetric relaxation constant Tau and duration of diastole of the left ventricle. | Periprocedural. | Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software. |
| Change in dPdtmin | Periprocedural. | Measurement will take place during TTVR with patient in general anesthesia. Measures will be made using a commercially available conductance catheter. Data analysis will be performed offline using a dedicated software. |
| Change in the early diastolic filling pattern as assessed by MRI. | Baseline and 1-month follow-up following TTVR. | All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner. |
Countries
Germany
Contacts
Primary ContactKarl-Patrik Kresoja, MD
Backup ContactPhilipp Lurz, MD, PhD
Outcome results
None listed