I36.1
Conditions
Interventions
Group 1: Investigating the safety, efficacy, and feasibility of a purely echocardiographic procedure planning and execution for EVOQUE implantation in selected patients with favorable anatomy and a lo
Sponsors
Medizinische Klinik III der Uniklinik Köln
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: -Age: At least 18 years -Severe symptomatic tricuspid regurgitation -Written informed consent -Willingness and ability to comply with the single outpatient follow-up visit at 30 days Anatomical Requirements: -Suitable annular dimensions (End-diastolic MPR [multiplanar reconstruction] perimeter: 114–160 mm) -Right heart dimensions: --Right atrial height (systole): >55 mm --Right ventricular depth (diastole): >40 mm -Leaflet integrity: --Absence of a flail leaflet --Absence of septal plastering (adherence of the septal leaflet to the septum) -Additional anatomical considerations: -No congenital heart defects -No rheumatic heart disease or carcinoid syndrome -No prior tricuspid valve interventions -Maximum of one transvalvular lead (e.g., pacemaker lead) -Adequate transesophageal echocardiography (TEE) image quality (at the discretion of the investigators)
Exclusion criteria
Exclusion criteria: Exclusion Criteria: -Institutionalization by judicial or administrative order (in accordance with §20 MPG [German Medical Devices Act]) -Pregnancy -Existing legal guardianship -Circumstances that complicate follow-up (e.g., lack of mobility, non-compliance, or language barriers)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraprocedural Success Based on TVARC Criteria To meet this endpoint, all of the following criteria must be fulfilled: -Absence of intraprocedural mortality or stroke -Successful vascular access, delivery, and retrieval of the delivery system -Successful deployment and correct positioning of the intended implant, without requiring the implantation of unplanned additional devices -Adequate function of the transcatheter implant. This includes the absence of tricuspid valve stenosis: tricuspid valve area >1.5 cm2 or indexed to body surface area >0.9 cm2/m2 [>0.75 if body mass index >30 kg/m2], doppler velocity index (DVI) <2.2, mean gradient <5 mmHg; and a reduction of total tricuspid regurgitation (TR) to mild [1+] or moderate [2+] -Absence of implant-related obstruction of forward flow -Absence of implant-related pulmonary embolism -No emergency surgery or reintervention within the first 24 hours related to the implant or the access route | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Success at 30 Days Based on TVARC Criteria To meet this endpoint, all of the following criteria must be fulfilled at 30 days: -Absence of procedure-related mortality or stroke -Correct positioning of the implant with adequate implant function. This includes the absence of tricuspid valve stenosis: tricuspid valve area >1.5 cm2 or indexed to body surface area >0.9 cm2/m2 [>0.75 if body mass index >30 kg/m2], doppler velocity index (DVI) Grade 3, amputation, or irreversible end-organ or neurological damage) c. Severe cardiac structural complications d. Acute kidney injury (AKI) Stage 2 or 3 (including new requirement for dialysis) e. Myocardial infarction or coronary ischemia requiring percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery f. Implant-related obstruction of forward flow g. Implant-related pulmonary embolism h. Any severe hemodynamic instability resulting in the need for heart transplantation, mechanical circulatory support (MCS), or extracorporale membrane oxygenation (ECMO) at day 30 i. Any valve-related dysfunction, migration, thrombosis, or other complication requiring surgery or reintervention Additional Secondary Endpoints: -Time from initial echocardiographic screening to procedure (in days) -Procedure duration (in minutes) -Cardiac rhythm and conduction disturbances, defined as new post-procedural left or right bundle branch block (LBBB/RBBB) or atrioventricular (AV) block -Renal function at discharge (measured as serum creatinine in mg/dl) | — |
Countries
Germany
Contacts
Public ContactMaria Isabel Körber
Medizinische Klinik III d. Uniklinik Köln
Outcome results
None listed