An interventional study of Meril Octapro+ THV System and Abbott Navitor/Navitor Vision THV system in Aortic Valve Stenosis, sponsored by Universitätsklinikum Hamburg-Eppendorf. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Not applicable, Interventional, and Treatment
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 25th largest by planned enrollment of the 92 interventional ones that give a count, is one of 5 that started in 2026, is one of 81 with no phase, reaches primary completion later than 44 of the 56 other live ones, and was the 188th 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 510 is above the median of 126 across 554 interventional 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.
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 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. 5 started in 2026.
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:
Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 416 studies on the registry; 86 are open to participants now.
Universitätsklinikum Hamburg-Eppendorf has 5 studies 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:
In Europe TAVI is now recommended for treatment of aortic valve stenosis from the age of 70 years. When performing TAVI in young patients, lifetime management becomes important in terms of anticipated TAVI-in-TAVI procedures when valve deterioration occures. Especially small aortic annuli represent a special challenge in terms of postprocedural hemodynamics, however intra-annular transcatheter heart valve designs should be the devices of choice to facilitate future TAVI-in-TAVI procedures. Which intra-annular valve design offers ideal clinical and hemodynamic efficacy is unclear. Therefore, an investigator-initiated, randomized controlled trial (BALANCE trial: Balloon- vs. Self-expanding intraannular TAVI in small aortic annuli) was created to elucidate this topic.
This is a prospective, multi-center, national, randomized controlled, post-market trial.
The primary objectives of the trial are to demonstrate clinical and hemodynamic non-inferiority of the Octapro+ System when compared to subjects treated with the Navitor System at 30 days and12 months post-procedure.
Subjects will be randomized on a 2:1 basis to receive TAVI with either a Meril Balloon-expanding (BE) intraannular Transcatheter Heart Valve (THV) or an Abbott Self-expanding (SE) intraannular THV. Data will be collected at pre- and post-procedure, at discharge, at 30 days, and once a year until the 5-year follow-up is completed.
Product Names:
Currently, there is no comparative evidence for clinical and hemodynamic efficacy of the two available intra-annular THV principles (BE vs. SE) for treatment of AS in patients with small aortic annuli.
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:
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Meril Octapro+ THV System
Device: Abbott Navitor/Navitor Vision THV system
TAVI treatment with Meril Octapro+ THV System
Also known as: Transcatheter aortic valve replacement
TAVI treatment with Abbott Navitor/Navitor Vision System
Also known as: Transcatheter aortic valve replacement
Early Safety according to VARC-3 Criteria
* Freedom from all-cause mortality * Freedom from all stroke * Freedom from VARC type 2-4 bleeding * Freedom from major vascular, access-related, or cardiac structural complication * Freedom from acute kidney injury stage 3 or 4 * Freedom from moderate or severe aortic regurgitation * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities * Freedom from surgery or intervention related to the device
Time frame: 30 Days
Hemodynamic performance (Mean aortic gradient)
\- Transvalvular mean pressure gradient ( mmHg, Continuous Variable)
Time frame: 12 Months and 5 Years
Paravalvular leakage ≥ moderate
Rate of significant paravalvular leakage (≥ moderate)
Time frame: 12 months and 5 years
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite Endpoint
Time frame: 5 Years
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
* Valve mean gradient of 20 mm Hg or higher * Incidence of Nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or at least moderate aortic regurgitation * Incidence of Clinical valve thrombosis; endocarditis * Incidence of Aortic-valve reintervention
Time frame: 5 Years
Rate of Permanent Pacemaker Implantation
Implantation of a Permanent Pacemaker due to Conduction disturbances
Time frame: 5 Years
Rate of Any Stroke
Minor, Major and Disabling Stroke
Time frame: 5 Years
New York Heart Association functional class compared to baseline
Symptom relief (Dyspnea)
Time frame: 5 Years
Left ventricular ejection fraction compared to baseline
Left Ventricular Function parameter
Time frame: 5 Years
Length of hospital stay at discharge
Length of hospital stay at discharge
Time frame: 30 Days
Technical success according to VARC-3 criteria
* Freedom from mortality * Successful access, delivery of 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: 30 Days
Device success according to VARC-3 criteria
* 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 mm Hg, peak velocity \< 3 m/s, Doppler velocity index ≥ 0.25, and less than moderate aortic regurgitation
Time frame: 30 Days
Rate of New onset of atrial fibrillation or atrial flutter
New onset of atrial fibrillation or atrial flutter
Time frame: 30 Days
Freedom from All-cause mortality, Disabling stroke and Rehospitalization
Composite endpoint
Time frame: 12 Months and 5 Years
Rate of Bioprosthetic valve failure and dysfunction (Combined endpoint)
* Valve mean gradient of 20 mm Hg or higher * Incidence of Nonstructural valve dysfunction, defined as severe prosthesis-patient mismatch or at least moderate aortic regurgitation * Incidence of Clinical valve thrombosis; endocarditis * Incidence of Aortic-valve reintervention
Time frame: 12 Months and 5 Years
Plan to share: Yes
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's planned 21 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf →