TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease
NCT ID: NCT05536310
Last Updated: 2023-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
600 participants
OBSERVATIONAL
2023-03-31
2027-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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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)
Transcatheter Aortic Valve Implantation (TAVI)
TAVI with the JenaValve Trilogy Heart Valve System
Interventions
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Transcatheter Aortic Valve Implantation (TAVI)
TAVI with the JenaValve Trilogy Heart Valve System
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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JenaValve Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephan Baldus, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Cologne Heart Center
Hendrik Treede, MD
Role: PRINCIPAL_INVESTIGATOR
Johannes Gutenberg University Mainz
Locations
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Herz-und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, , Germany
University Hospital of Cologne Heart Center
Cologne, , Germany
University Hospital Mainz
Mainz, , Germany
Countries
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Central Contacts
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Vinny Podichetty, Vice President: Clinical & Med Affairs
Role: CONTACT
Facility Contacts
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Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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CLIN-0099
Identifier Type: -
Identifier Source: org_study_id
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