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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter tricuspid valve edge-to-edge repair | Experimental | Patients will undergo transcatheter tricuspid valve edge-to-edge repair (TTVR) and hemodynamic characteristics will be analysed on a multimodal approach using cardiac magnetic resonance imaging and pressure volume loop analysis before and after TTVR. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcatheter tricuspid valve edge-to-edge repair | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Periprocedural change in enddiastolic pressure volume relationship of the left ventricle | 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. | Periprocedural. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the estimated left ventricular end diastolic volume at 10 mmHg as estimated by the left ventricular pressure volume relationship (LVEDPVR) | 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. | Periprocedural. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl-Patrik Kresoja, MD | Contact | 0341865252596 | karl-patrik.kresoja@medizin.uni-leipzig.de | |
| Philipp Lurz, MD, PhD | Contact | 0341865252529 | philipp.lurz@medizin.uni-leipzig.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Centre at University Leipzig | Recruiting | Leipzig | Saxony | 04289 | Germany |
Anonymized data will be made available on reasonable cooperation request.
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D014262 | Tricuspid Valve Insufficiency |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006349 | Heart Valve Diseases |
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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
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Outcome assessors will be blinded whether they are analysing pre or post transcatheter tricuspid valve edge-to-edge repair data.
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| Change in the ratio of isovolumetric relaxation constant "Tau" and duration of diastole of the left ventricle. | 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. | Periprocedural. |
| Change in dPdtmin | 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. | Periprocedural. |
| Change in the early diastolic filling pattern as assessed by MRI. | All patients will receive MRI before and 1-month after TTVR on a 1.5 tesla scanner. | Baseline and 1-month follow-up following TTVR. |