An observational study in Transcatheter Aortic Valve Replacement (TAVR), Aortic-Stenosis and Aortic Insufficiency, sponsored by Institut für Pharmakologie und Präventive Medizin. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Institut für Pharmakologie und Präventive Medizin · Observational
Among 17 studies in Aortic Valve Stenosis by Institut für Pharmakologie und Präventive Medizin — 1 open to participants now, 2 under way, none of them phase 3. Aortic Valve Stenosis · Institut für Pharmakologie und Präventive Medizin.
Among the 17 studies in Aortic Valve Stenosis by Institut für Pharmakologie und Präventive Medizin, this one is the 6th largest by planned enrollment, is one of 2 that started in 2025, is one of 17 observational ones, and was the 17th 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 500 is above the median of 200 across 435 observational studies indexed under Aortic Valve Stenosis.
Browse Aortic Valve Stenosis studies →1 of the 17 studies in Aortic Valve Stenosis by Institut für Pharmakologie und Präventive Medizin is open now, in 1 country. 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 →17 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 2 started in 2025.
Median enrollment 300 across the 17 observational studies. Of the 15 that completed or were terminated, 0 (0%) have results posted.
Institut für Pharmakologie und Präventive Medizin is the lead sponsor of 30 studies on the registry; 4 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 17 studies in Aortic Valve Stenosis by Institut für Pharmakologie und Präventive Medizin, from their registry updates:
Nothing recorded among them since 2026-09-25.
Evaluation of clinical outcomes and valve performance of the SAPIEN 3 Ultra Resilia (S3UR) valve over 10 years.
Transcatheter aortic valve replacement (TAVI) has become the gold standard treatment for moderate-to-high risk elderly patients with severe symptomatic aortic stenosis. Based on the results of randomized trials including low risk patients, this treatment has been progressively applied to younger (in the sixties and seventies) patients with a low co-morbidity burden. Life expectancy in this group is expected to extend beyond 5 years from intervention in the vast majority of patients, and beyond 10 years in a high proportion. Thus, the issue of valve durability has become one of the most important aspects in the TAVI field in recent years. To date, the rates of bioprosthetic valve failure at 8-10 years after TAVI have been consistently \<10%, but some studies have shown some degree of valve structural degeneration in close to one third of the patients at 8-year follow-up. This subclinical valve degeneration before the 10-year follow-up landmark would represent the initial step in the process of bioprosthetic valve failure, and further valve degeneration leading to clinical symptoms is likely to occur in a significant proportion of these cases.
This prospective registry will evaluate the clinical outcomes and the valve performance of the SAPIEN 3 Ultra RESILIA valve over 10 years.
Adult patiets with severe aortic stenosis planned to undergo TAVR on their native valve with a SAPIEN 3 Ultra RESILIA 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.
Exclusion criteria:
Critieria for long-term observation (1y-10y):
Technical success at exit from procedure room (VARC-3):
Absence of the following severe procedural and in-hospital complications (VARC-3 definitions):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult patients with severe aortic stenosis undergoing transfemoral TAVI on their native valve with S3UR valve
Procedure: Transcatheter aortic valve (S3UR) replacement (TAVR)
Elective transfemoral TAVi procedure with S3UR valve.
Early Safety
Early safety acc. to VARC-3
Time frame: 1-3 months
Device Success
Device Success acc. to VARC-3
Time frame: 1-3 months
Bioprosthetic Valve Failure
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operations/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Time frame: 3-5 years
Bioprosthetic Valve Failure
Bioprosthetic valve failure (defined as valve-related mortality OR aortic valve re-operation/re-intervention OR stage 3 hemodynamic valve deterioration (VARC-3))
Time frame: 9-10 years
Structural Valve Deterioration
Structural Valve Deterioration ≥ stage 2 (VARC-3)
Time frame: 9-10 years
Hemodynamic Valve Performance
* Prosthetic valve regurgitation including paravalvular regurgitation * Mean transvalvular gradient * Max transvalvular gradient * Effective orifice area
Time frame: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)
Bioprosthetic Valve Failure
Bioprosthetic Valve Failure acc. to VARC-3
Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year 9-10 year)
Bioprosthetic Valve Dysfunction
BVD acc. to VARC-3
Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Patient reported outcomes
Patient reported outcomes using TASQ questionnaire and EQ-5D questionnaire
Time frame: 1-3month, 1+3year Follow Up compared to BL
Cumulated incidence rate BVD or BVF
Cumulated incidence rate (per 100 patient-years) of bioprosthetic valve dysfunction (stage 2 or 3) OR bioprosthetic valve failure up to 10-year follow-up
Time frame: Up to 10 years
Clinical Events
Clinical events (mortality, stroke, bleeding type 2-4, cardiac rehospitalization, heart failure rehospitalization)
Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Hemodynamic valve deterioration stage 2 and 3 (VARC-3)
HVD stage 2 and 3 according to VARC-3 Criteria (moderate and severe HVD).
Time frame: All follow-ups (1-3 month, 1year, 3-5 year, 6-8 year, 9-10 year)
Overall kidney function
Kidney function assessed through lab values: eGFR in ml/min/1,73m2; creatinine in mg/dl or micromol/l; albumin-to-creatinin-ratio in mg/g; serum calcium in mg/dl or millimol/l ; serum phosphate in mg/dl or millimol/l ; PTH intact in pmol/l, pg/ml or ng/l; Hb in g/l, g/dl, millimol/l
Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Overall Lipid Status
Lipid status assessed through lab values: total cholesterol in mg/dl, millimol/l or micromol/l; LDL in millimol/l or micromol/l; HDL millimol/l or micromol/l;Triglycerides in mg/dl, millimol/l or micromol/l; latest HbA1c in %; Lp(a) in mg/dl or nmol/l
Time frame: All follow-ups (1-3month, 1year, 3-5 year, 6-8year, 9-10 year)
Plan to share: No — no individual participant data (IPD) will be shard
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for May 2037, 140 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 140 months is above that.
Counting every sponsor, half of 242 studies reached it within 42 months; a quarter within 23 and three quarters within 86.
How these figures are worked out, and which studies are left out of them.
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Institut für Pharmakologie und Präventive Medizin