Aortic Valve Stenosis Clinical Trial
— TAVISOfficial title:
Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease: Patient Registry and Post-Market Clinical Follow-up Study
NCT number | NCT05536310 |
Other study ID # | CLIN-0099 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2023 |
Est. completion date | October 2027 |
To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | October 2027 |
Est. primary completion date | October 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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 2. 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 3. Patients 18 years of age or older 4. Patient is willing to participate in the study, provides signed Informed Consent/Data Authorization Form and authorizes the sharing of data in the study 5. The subject and treating physician agree the subject will return for all required post-procedure follow-up visits Exclusion Criteria: 1. 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 2. Patients who have active bacterial endocarditis or other active infections 3. Pediatric (<18 years) and/or pregnant/nursing patients 4. Congenital/functional unicuspid, bicuspid or quadricuspid native aortic valve morphology 5. Previous prosthetic aortic valve (bioprosthesis or mechanical) implant 6. Echocardiographic evidence of current left heart thrombus 7. Hypertrophic cardiomyopathy with or without obstruction. 8. 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. |
Country | Name | City | State |
---|---|---|---|
Germany | Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen | Bad Oeynhausen | |
Germany | University Hospital of Cologne Heart Center | Köln | |
Germany | University Hospital Mainz | Mainz |
Lead Sponsor | Collaborator |
---|---|
JenaValve Technology, Inc. |
Germany,
Hamid 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. — View Citation
Iung 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. — View Citation
Ng 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. — View Citation
Nishimura 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. — View Citation
Poschner 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. — View Citation
Treede H, Rastan A, Ferrari M, Ensminger S, Figulla HR, Mohr FW. JenaValve. EuroIntervention. 2012 Sep;8 Suppl Q:Q88-93. doi: 10.4244/EIJV8SQA16. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-cause mortality | Mortality from any cause in patients receiving TAVI for AR or AS | 30-days post-index procedure | |
Secondary | Death | Reported death in patients participating in TAVIS Registry | 1 year | |
Secondary | Stroke | Reported stroke in patients participating in TAVIS Registry | 30 days and 1 year | |
Secondary | Major vascular complications | Reported vascular complications in patients participating in TAVIS Registry | 30 days | |
Secondary | Major and life-threatening bleeding | Reported major and life-threatening bleeding complications in patients participating in TAVIS Registry | 30 days | |
Secondary | New conduction defects requiring permanent pacemaker | Reported conduction defects requiring permanent pacemaker in patients participating in TAVIS Registry | 30 days | |
Secondary | Acute kidney injury stage 2-3 | Reported kidney injury complications in patients participating in TAVIS Registry | 7 days | |
Secondary | New onset atrial fibrillation | Reported new onset atrial fibrillation in patients participating in TAVIS Registry | 30 days |
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