Aortic Valve StenosisTAVISNCT05536310
TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
An observational study of Aortic Valve Stenosis and Aortic Valve Regurgitation, run by JenaValve Technology, Inc. at 3 sites in Germany.
Trial summary
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency
- What is being tested?
- Transcatheter Aortic Valve Implantation (TAVI)
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Aug 2023to 9 Jul 2024
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic severe aortic regurgitation or symptomatic severe aortic stenosis undergoing treatment with JenaValve Trilogy Heart Valve System
Who may be able to join
- Patients who have signed ICF and are indicated by their doctors to be treated with Trilogy Heart Valve System in line with the medical standard of care
- Patients with symptomatic severe aortic regurgitation (AR) or symptomatic, severe aortic stenosis (AS), who are at high risk for SAVR as documented by the heart team and Heart Team agrees that patient can undergo SAVR for "bail out"/to address unfavorable circumstances if necessary
- Patients 18 years of age or older
- Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study
- The subject and treating physician agree the subject will return for all required post-procedure follow-up visits
Who cannot join
- Patients who have known hypersensitivity or contraindication to Nitinol (titanium and/or nickel), an anti-coagulation/anti-platelet regimen or contrast medium that cannot be managed with premedication
- Patients who have active bacterial endocarditis or other active infections
- Pediatric (<18 years) and/or pregnant/nursing patients
- Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology
- Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
- Echocardiographic evidence of current left heart thrombus
- Hypertrophic cardiomyopathy with or without obstruction.
- Access vessel characteristics that would preclude safe placement of the JenaValve 20Fr introducer sheath, such as severe obstructive calcification, severe tortuosity, or vessel diameter <7mm.
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, 32545
University Hospital of Cologne Heart Center
Cologne, 50937
University Hospital Mainz
Mainz, 55131
About this study
Official title: Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
Read the detailed description
Aortic stenosis (AS) is a narrowing of the aortic valve opening causing restricted blood flow from the left ventricle to the aorta and may also affect the pressure in the left atrium. Aortic regurgitation (AR) is a condition where the aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of AS and AR may include fatigue and shortness of breath. Aortic valve disease can affect both elderly and younger populations. TAVIS Registry will collect data from patients suffering from either AS or AR using a minimally invasive transcatheter aortic valve implantation procedure.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Regurgitation, Aortic Valve Stenosis With Insufficiency, Constriction, Pathologic, Aortic Valve Disease, Heart Valve Diseases
- Being tested
- Transcatheter Aortic Valve Implantation (TAVI)
- Keywords
- Trilogy, Aortic Valve Disease, Transcatheter aortic valve replacement (TAVR), Aortic Valve Regurgitation
- Medical subject headings
- Aortic Valve Stenosis, Aortic Valve Insufficiency, Constriction, Pathologic, Aortic Valve Disease, Heart Valve Diseases, Ventricular Outflow Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter Aortic Valve Implantation (TAVI)Device
TAVI with the JenaValve Trilogy Heart Valve System
| Study group | Role | What they receive |
|---|---|---|
| Trilogy TAVI | Patients receiving JenaValve Trilogy Heart Valve System for management of symptomatic, severe aortic stenosis (AS)/ aortic regurgitation (AR) who are at high risk for surgical aortic valve replacement (SAVR) Receives: Device: Transcatheter Aortic Valve Implantation (TAVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Mortality from any cause in patients receiving TAVI for AR or AS
Measured: 30-days post-index procedure
Secondary outcomes (7)
Death
Reported death in patients participating in TAVIS Registry
Measured: 1 year
Stroke
Reported stroke in patients participating in TAVIS Registry
Measured: 30 days and 1 year
Major vascular complications
Reported vascular complications in patients participating in TAVIS Registry
Measured: 30 days
Major and life-threatening bleeding
Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry
Measured: 30 days
New conduction defects requiring permanent pacemaker
Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry
Measured: 30 days
Acute kidney injury stage 2-3
Reported kidney injury complications in patients participating in TAVIS Registry
Measured: 7 days
New onset atrial fibrillation
Reported new onset atrial fibrillation in patients participating in TAVIS Registry
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Aug 2023
- Primary completion9 Jul 2024
- Study completion9 Jul 2024
Why it stopped: Inadequate study design which restricted study enrollment suitable for a registry.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- JenaValve Technology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephan Baldus, MD, Principal investigator, University Hospital of Cologne Heart CenterHendrik Treede, MD, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05536310
- Sponsor's protocol ID
- CLIN-0099
- Acronym
- TAVIS
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Zoghbi WA, Adams D, Bonow RO, Enriquez-Sarano M, Foster E, Grayburn PA, Hahn RT, Han Y, Hung J, Lang RM, Little SH, Shah DJ, Shernan S, Thavendiranathan P, Thomas JD, Weissman NJ. Recommendations for Noninvasive Evaluation of Native Valvular Regurgitation: A Report from the American Society of Echocardiography Developed in Collaboration with the Society for Cardiovascular Magnetic Resonance. J Am Soc Echocardiogr. 2017 Apr;30(4):303-371. doi: 10.1016/j.echo.2017.01.007. Epub 2017 Mar 14. No abstract available.
PubMed 28314623Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017 Jun 20;135(25):e1159-e1195. doi: 10.1161/CIR.0000000000000503. Epub 2017 Mar 15. No abstract available.
PubMed 28298458Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Barwolf C, Levang OW, Tornos P, Vanoverschelde JL, Vermeer F, Boersma E, Ravaud P, Vahanian A. A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. Eur Heart J. 2003 Jul;24(13):1231-43. doi: 10.1016/s0195-668x(03)00201-x.
PubMed 12831818Hamid N, Ranard LS, Khalique OK, Hahn RT, Nazif TM, George I, Ng V, Leon MB, Kodali SK, Vahl TP. Commissural Alignment After Transfemoral Transcatheter Aortic Valve Replacement With the JenaValve Trilogy System. JACC Cardiovasc Interv. 2021 Sep 27;14(18):2079-2081. doi: 10.1016/j.jcin.2021.07.025. No abstract available.
PubMed 34556282Treede H, Rastan A, Ferrari M, Ensminger S, Figulla HR, Mohr FW. JenaValve. EuroIntervention. 2012 Sep;8 Suppl Q:Q88-93. doi: 10.4244/EIJV8SQA16.
PubMed 22995119Poschner T, Werner P, Kocher A, Laufer G, Musumeci F, Andreas M, Russo M. The JenaValve pericardial transcatheter aortic valve replacement system to treat aortic valve disease. Future Cardiol. 2022 Feb;18(2):101-113. doi: 10.2217/fca-2021-0065. Epub 2021 Oct 14.
PubMed 34647465Ng VG, Khalique OK, Nazif T, Patel A, Hamid N, George I, Bapat V, Hahn R, Kodali S, Vahl TP. Treatment of Acute Aortic Insufficiency With a Dedicated Device. JACC Case Rep. 2021 Mar 24;3(4):645-649. doi: 10.1016/j.jaccas.2021.01.021. eCollection 2021 Apr.
PubMed 34317595