An observational study in Aortic Valve Stenosis, sponsored by The Leeds Teaching Hospitals NHS Trust. Active, not recruiting at 63 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by The Leeds Teaching Hospitals NHS Trust · Observational
Among 190 studies in Aortic Valve Stenosis with a site in Germany — 38 open to participants now, 57 under way, 3 of them phase 3. Aortic Valve Stenosis · Germany.
Among the 190 studies in Aortic Valve Stenosis with a site in Germany, this one is the 37th largest by planned enrollment of the 98 observational ones that give a count, is one of 7 that started in 2025, is one of 98 observational ones, reaches primary completion later than 37 of the 56 other live ones, and was the 173rd registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
This study's planned enrollment of 550 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →38 of the 190 studies in Aortic Valve Stenosis with a site in Germany are open now, in 12 countries. Each count lists the studies.
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →190 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 7 started in 2025.
Median enrollment 217 across the 92 interventional studies, 300 across the 98 observational. Of the 109 that completed or were terminated, 28 (26%) have results posted.
92 of 190 have an industry lead sponsor. The 10 most frequent:
The Leeds Teaching Hospitals NHS Trust is the lead sponsor of 101 studies on the registry; 15 are open to participants now.
The Leeds Teaching Hospitals NHS Trust has 1 study filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
7 of the studies in Aortic Valve Stenosis 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 |
|---|---|
| NCT07479992Idoven 1903 S.L.Multicenter Study for the Validation of Willem AI: Aortic StenoSis Early Diagnosis With AI-electrocardiogram Study | 2027-01 |
| NCT06493994University of LuebeckMyval TransAXillary Transcatheter Aortic Valve Replacement Multicenter Clinical Registry | 2027-01-30 |
| 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 |
| NCT05603520Heinrich-Heine University, DuesseldorfPhenotyping Heterogeneity and Regionality of the Aorta | 2027-06-30 |
Among the 190 studies in Aortic Valve Stenosis with a site in Germany, from their registry updates:
Transcatheter aortic valve implantation (TAVI) is a key-hole technique to replace an aortic heart valve that is narrowed and/or leaking. Although TAVI is a safe and effective treatment for a faulty aortic heart valve, the new TAVI valve will not last forever. Because it is a 'tissue' valve (made from the lining of a cow or pig heart), the valve will fail after a period of time as the tissue degenerates.
When the TAVI valve fails, a viable treatment option is to perform a 'Redo TAVI' procedure, implanting a second TAVI valve inside the first failing valve.
The main purpose of this study is to carefully evaluate patients being treated by Redo TAVI in order to document the short-term and long-term outcomes of the procedure. The study will also obtain information about which factors predict those outcomes.
The study will also assess outcomes in patients who present with TAVI valve failure but are not suitable for Redo TAVI, and instead are treated either by open-heart surgery and surgical aortic valve replacement, or by medical therapy (medication).
The study will provide doctors the information they need to understand the best way to treat patients who present with TAVI valve failure, and in particular how to perform Redo TAVI procedures with the best possible outcomes for patients.
To determine the acute and long-term outcomes of Redo Transcatheter Aortic Valve Implantation (TAVI) for the treatment of Bioprosthetic Valve Failure (BVF) affecting Transcatheter Aortic Heart Valves (THVs)
To determine the factors which predict the acute and long-term outcomes of Redo TAVI
To determine the proportion of patients presenting with BVF affecting THVs who are deemed unsuitable for Redo TAVI by the Heart Team
To determine the acute and long-term outcomes of surgical explantation and aortic valve replacement (AVR) for the treatment of BVF affecting THVs
To determine the survival of patients presenting with BVF affecting THVs who are managed conservatively - including optimal medical therapy (OMT) +/- balloon aortic valvuloplasty (BAV)
All patients presenting to the Heart Team with bio-prosthetic valve failure affecting a transcatheter aortic valve
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.
1. Bio-prosthetic Valve Failure (BVF) of a Transcatheter Aortic Valve requiring possible reintervention
Exclusion Criteria:
Redo Trans-catheter Aortic Valve Implantation for Bioprosthetic Valve Failure of a Trans-catheter Aortic Valve
Device: Any commercially available Edwards or Medtronic transcatheter aortic valve with the TAV-in-TAV (Redo TAVI) indication
Surgical explantation with aortic valve replacement
Procedure: Surgical explantation and aortic valve replacement
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
Other: Conservative management
Redo TAVI will be performed using any commercially available Edwards or Medtronic transcatheter aortic valve platforms that have the TAV-in-TAV (Redo TAVI) indication according to the preferences of the local team in keeping with standard clinical care.
Surgical explantation of all or part of the index transcatheter aortic valve, with open implantation of a new surgical or transcatheter aortic valve replacement will be performed according to the preferences of the local team in keeping with standard clinical care. Any commercially available approved surgical or transcatheter aortic valve may be used. Additional surgery, such as aortic root replacement, root enlargement, CABG, mitral valve repair/replacement, etc. will be performed at the discretion of the local team.
Conservative treatment, including optimal medical therapy +/- balloon aortic valvuloplasty
REVALVE success (Redo TAVI)
Correct positioning of a single prosthetic heart valve into the proper anatomic location, intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25. aortic regurgitation \< moderate), Freedom from mortality, coronary obstruction, unplanned coronary revascularisation, surgery or intervention related to the device
Time frame: 30 days
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (Redo TAVI)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Time frame: 12 months
Valve Academic Research Consortium 3 (VARC3) Early Safety (EXPLANT)
Composite outcome of freedom from: death/stroke/VARC 3-4 bleeding/major vascular, access-related, or cardiac structural complication/AKI 3 or 4/moderate or severe AR/new permanent pacemaker/device-related surgery or intervention
Time frame: 30 days
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (EXPLANT)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Time frame: 12 months
Freedom from death/stroke/re-hospitalisation for valve or procedure-related causes (OMT)
Composite outcome of freedom from death/stroke/re-hospitalisation for valve or procedure-related causes
Time frame: 12 months
Valve Academic Research Consortium 3 (VARC3) Technical Success (Redo TAVI and EXPLANT)
Freedom from mortality, successful access, delivery of the device, and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication
Time frame: End of procedure
Valve Academic Research Consortium 3 (VARC3) Device Success (Redo TAVI and EXPLANT)
Technical success, Freedom from mortality, Freedom from surgery or intervention related to the device, or to a major vascular or access-related or cardiac structural complication, Intended performance of the valve (mean gradient \<20 mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, aortic regurgitation \< moderate)
Time frame: 30 days
Valve Academic Research Consortium 3 (VARC3) Early Safety (Redo TAVI)
Freedom from: death/stroke/VARC 2-4 bleeding (only VARC 3-4 for EXPLANT) /major vascular, access-related, or cardiac structural complication/Acute kidney injury (AKI) 3 or 4/moderate or severe Aortic Regurgitation/new permanent pacemaker/device-related surgery or intervention
Time frame: 30 days
Peak and mean invasive gradient post-procedure (Redo TAVI)
Invasive pressure measurements
Time frame: End of procedure
In-hospital Clinical Outcomes
All-cause mortality; All stroke; Myocardial infarction; Coronary artery obstruction; Unplanned coronary revascularisation (PCI or CABG); Bleeding (VARC 1-4); Major or minor Vascular and access-related complications; Cardiac structural complications; Permanent pacemaker implantation; Acute kidney injury (AKI) stage 1-4; Endocarditis; Clinically significant valve thrombosis
Time frame: Immediately after the procedure/surgery
Echocardiographic Assessment: Peak velocity
Peak velocity
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Mean gradient
Mean gradient
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Aortic valve area
Aortic valve area
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Patient-prosthesis mismatch
Patient-prosthesis mismatch
Time frame: Pre-discharge or at 30 days
Echocardiographic Assessment: Aortic Regurgitation - paravalvular, transvalvular or total
Aortic Regurgitation - paravalvular, transvalvular or total
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Echocardiographic Assessment: Left ventricular systolic function
Left ventricular systolic function
Time frame: Pre-discharge or at 30 days, 1, 3, 5 years
Clinical Outcomes
All-cause mortality; Cardiovascular mortality; Valve-related mortality; Hospitalisation; Cardiovascular hospitalisation; Hospitalisation for valve or procedure-related causes; All stroke; Myocardial infarction; Coronary angiography; Coronary revascularization; Bioprosthetic valve dysfunction: i. Structural valve deterioration; ii. Non-structural valve deterioration (Prosthesis-patient mismatch, Paravalvular aortic regurgitation, Other) iii. Thrombosis iv. Endocarditis; Bioprosthetic valve failure; Aortic valve re-intervention
Time frame: 1, 3 and 5 years
Plan to share: No
Started Feb 2025 (actual). Primary completion is estimated for Dec 2027, 34 months after the start.
Of 205 non-industry observational studies under Aortic Valve Stenosis, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 120. This study's planned 34 months is below that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 26, 2026: start Dec 2024 → Feb 2025, primary completion Jun 2027 → Dec 2027 and completion Mar 2033 → Nov 2031.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The Leeds Teaching Hospitals NHS Trust →