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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ACTIVE_NOT_RECRUITING
NA
180 participants
INTERVENTIONAL
2020-05-22
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System
JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Interventions
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JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System
Eligibility Criteria
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Inclusion Criteria
* Patient at high risk for open surgical valve replacement
* Patient symptomatic according to NYHA functional class II or higher
* The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.
Exclusion Criteria
* Previous prosthetic aortic valve (bioprosthesis or mechanical) implant
* Endocarditis or other active infection
* Need for urgent or emergent TAVR procedure for any reason
* Cardiogenic shock or hemodynamic instability requiring inotropic support or ventricular assist device
* Severe mitral regurgitation
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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Martin B. Leon, MD
Role: STUDY_CHAIR
New York-Presbyterian/ Columbia University Medical Center
Torsten P. Vahl, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian/ Columbia University Medical Center
Vinod H. Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Healthcare
Locations
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TMC HealthCare & PIMA Heart
Tucson, Arizona, United States
Cedars Sinai Medical Center
Los Angeles, California, United States
Scripps Hospital
San Diego, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Morton Plant/ BayCare Health
Clearwater, Florida, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health
Oak Lawn, Illinois, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Minneapolis Heart Institute/ Abbott Northwestern
Minneapolis, Minnesota, United States
Barnes-Jewish Hospital / Washington University
St Louis, Missouri, United States
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital
Piscataway, New Jersey, United States
New York-Presbyterian/ Columbia University Medical Center
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Allegheny-Singer Health Network
Pittsburgh, Pennsylvania, United States
Lankenau
Wynnewood, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Methodist Le Bonheur Healthcare
Memphis, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Houston Methodist
Houston, Texas, United States
Memorial Hermann - Texas Medical Center
Houston, Texas, United States
Intermountain Medical Center Heart Institute
Salt Lake City, Utah, United States
Sentara Hospitals
Norfolk, Virginia, United States
University of Washington
Seattle, Washington, United States
Countries
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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.
Geyer M, Tamm AR, Munzel T, Treede H, von Bardeleben RS. Novel Transfemoral TAVR System to Treat Aortic Regurgitation in Degenerated Surgical Aortic Valve Replacement Even in Unfavorable Anatomy. JACC Cardiovasc Interv. 2022 Jun 13;15(11):e135-e136. doi: 10.1016/j.jcin.2022.02.043. Epub 2022 May 11. No abstract available.
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.
Vahl TP, Thourani VH, Makkar RR, Hamid N, Khalique OK, Daniels D, McCabe JM, Satler L, Russo M, Cheng W, George I, Aldea G, Sheridan B, Kereiakes D, Golwala H, Zahr F, Chetcuti S, Yadav P, Kodali SK, Treede H, Baldus S, Amoroso N, Ranard LS, Pinto DS, Leon MB. Transcatheter aortic valve implantation in patients with high-risk symptomatic native aortic regurgitation (ALIGN-AR): a prospective, multicentre, single-arm study. Lancet. 2024 Apr 13;403(10435):1451-1459. doi: 10.1016/S0140-6736(23)02806-4. Epub 2024 Mar 26.
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.
Other Identifiers
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P02C320
Identifier Type: -
Identifier Source: org_study_id
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