An interventional study of Transfemoral transcatheter valve-in-valve implantation and Surgical redo aortic valve replacement in Degenerative Aortic Valve Disease, sponsored by Heart Center Leipzig - University Hospital. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Heart Center Leipzig - University Hospital · Not applicable, Interventional, and Treatment
Among 44 studies in Aortic Valve Disease with a site in Germany — 10 open to participants now, 13 under way, none of them phase 3. Aortic Valve Disease · Germany.
Among the 44 studies in Aortic Valve Disease with a site in Germany, this one is the 3rd largest by planned enrollment of the 23 interventional ones that give a count, is one of 2 that started in 2025, is one of 22 with no phase, reaches primary completion later than 12 of the 12 other live ones, and was the 42nd registered.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's planned enrollment of 890 is above the median of 111 across 125 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →10 of the 44 studies in Aortic Valve Disease with a site in Germany are open now.
A study can be open while its sites in Germany have not opened yet or have stopped. Only those recruiting at a site in Germany →
Of the 46 Aortic Valve Disease studies recruiting now, 34 (74%) set no upper age limit and 5 (11%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 2 started in 2025.
Median enrollment 155 across the 23 interventional studies, 260 across the 21 observational. Of the 26 that completed or were terminated, 8 (31%) have results posted.
31 of 44 have an industry lead sponsor. The 10 most frequent:
Heart Center Leipzig - University Hospital is the lead sponsor of 21 studies on the registry; 5 are open to participants now.
Heart Center Leipzig - University Hospital has 1 study filed under Aortic Valve Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Aortic Valve Disease with a site in Germany that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07120048Edwards LifesciencesReal World Data Collection on the INSPIRIS RESILIA Aortic Valve | 2026-12 |
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
| NCT07520591Cardiawave SAValvosoft Outcomes Registry for Real-World Evidence | 2027-06-30 |
Among the 44 studies in Aortic Valve Disease with a site in Germany, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Procedure: Transfemoral transcatheter valve-in-valve implantation
Surgical redoAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
Procedure: Surgical redo aortic valve replacement
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.
Surgical rAVR serves as the control intervention. The patient's degenerated aortic bioprosthesis is replaced using conventional open-heart surgery.
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.
based on VARC-3
Time frame: 5 years
Each of the individual components of the primary composite endpoint
based on VARC-3
Time frame: 5 years
Valve Academic Research Consortium-3 (VARC-3)1-based conduction disturbances and arrhythmia
VARC-3-based conduction disturbances and arrhythmia (qualitative variable; yes or no)
Time frame: 5 years
Wound and bleeding complications (based on Bleeding Academic Research Consortium class 3b-5)
BARC-based bleeding complications (qualitative ordinal variable; 3b-5)
Time frame: 5 years
New York Heart Association classification III or IV
New York Heart Association classification (qualitative variable; III or IV)
Time frame: 5 years
Health status evaluated by the Kansas City Cardiomyopathy Questionnaire
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.
Time frame: 5 years
Health status evaluated by the SF-36 questionnaire
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).
Time frame: 5 years
Six-minute walk test
six-minute walk test (quantitative continuous variable)
Time frame: 5 years
Treatment Costs per quality adjusted life year Assessment of Safety
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.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Sep 2033, 94 months after the start.
Of 61 interventional studies with no phase under Aortic Valve Disease, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 61. This study's planned 94 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Heart Center Leipzig - University Hospital