Degenerative Aortic Valve Disease
Conditions
Brief summary
The overall hypothesis is that redo aortic valve replacement (rAVR) is superior to valve-invalve transcatheter aortic valve replacement (ViV-TAVR) for the composite endpoint of freedom from all-cause mortality, all-cause stroke, myocardial infarction, and rehospitalization for heart failure or aortic valve re-intervention at 5 years.
Interventions
PROCEDURETransfemoral transcatheter valve-in-valve implantation
The intervention under investigation is transcatheter \- preferably transfemoral - ViV-TAVR applied for degenerated surgical aortic bioprostheses with an indication for re-intervention in patients at low-to intermediate surgical risk. An aortic transcatheter bioprosthesis is implanted into the degenerated surgical aortic bioprosthesis.
PROCEDURESurgical redo aortic valve replacement
Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
Sponsors
Heart Center Leipzig - University Hospital
University of Leipzig
Helios Health Institute GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Indication for repeat intervention for failed surgical aortic bioprosthesis due to structural valve deterioration (SVD; prosthesis stenosis and/or transprosthetic insufficiency); * Low to intermediate surgical risk (i.e., Society of Thoracic Surgeons (STS) predicted risk of mortality of \< 8%); * Age \> 18 and \< 75 years; * Both rAVR and ViV-TAVR are judged to be reasonable options based on evaluation by the local Heart Team
Exclusion criteria
* Multiple valvular disease requiring surgical intervention; * High-risk coronary anatomy resulting in increased risk of coronary obstruction following ViV-TAVR prosthesis deployment; * Complex coronary artery disease requiring revascularization (unprotected left main coronary artery, Syntax score \> 32) and Heart Team assessment that optimal revascularization cannot be performed; * Failing valve with evidence of bacterial endocarditis or evidence of non-structural valve deterioration (e.g., paravalvular leak, thrombosis); * Increased post-procedural gradients (mean \> 20 mmHg) or severe patient-prosthesis mismatch (PPM, indexed effective orifice area \< 0.65 cm2/m2) at discharge from index aortic valve replacement (AVR) procedure; * Patients who choose to receive a mechanical AVR.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint will be a composite endpoint including all-cause mortality, all-cause stroke, myocardial infarction, and re-hospitalization for heart failure or aortic valve reintervention at 5 years. | 5 years | based on VARC-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Each of the individual components of the primary composite endpoint | 5 years | based on VARC-3 |
| Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia | 5 years | VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no) |
| Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5) | 5 years | BARC-based bleeding complications (qualitative ordinal variable; 3b-5) |
| New York Heart Association classification III or IV | 5 years | New York Heart Association classification (qualitative variable; III or IV) |
| Health status evaluated by the Kansas City Cardiomyopathy Questionnaire | 5 years | The KCCQ score, short for Kansas City Cardiomyopathy Questionnaire score, is a disease-specific, patient-reported score used to assess health status in heart failure. It consists of 23 items that assess symptoms, quality of life, and the impact of the disease on physical and social functioning over the past two weeks. Each area is transformed on a scale of 0 to 100, with higher scores indicating better health status. A difference of 5 points is considered clinically relevant, both for improvement and deterioration. |
| Health status evaluated by the SF-36 questionnaire | 5 years | The SF-36 measures 3 aspects of health (functional status, wellbeing, overall evaluation of health) using 8 separate scales. Scores are weighted and transformed into a scale ranging from 0 (greatest possible health restrictions, i.e., severe disability) to 100 (no health restrictions). |
| Six-minute walk test | 5 years | six-minute walk test (quantitative continuous variable) |
| Treatment Costs per quality adjusted life year Assessment of Safety | 5 years | This data will be collected for participating sites of countries in which this data is available. In patient costs will be measured through the collection of hospital billing and resource utilization information. |
Countries
Germany
Contacts
CONTACTMichael Borger
CONTACTMatthias Raschpichler
PRINCIPAL_INVESTIGATORMichael Borger
University Leipzig
Outcome results
None listed