Aortic Valve Disease Clinical Trial
— ALIGN-AROfficial title:
A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)
Verified date | September 2022 |
Source | JenaValve Technology, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | August 2028 |
Est. primary completion date | August 29, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient with severe aortic regurgitation (AR). - 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: - Congenital uni or bicuspid aortic valve morphology - 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Emory University Hospital | Atlanta | Georgia |
United States | Piedmont Healthcare | Atlanta | Georgia |
United States | University of Maryland Medical Center | Baltimore | Maryland |
United States | Medical University of South Carolina | Charleston | South Carolina |
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Morton Plant/ BayCare Health | Clearwater | Florida |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Ohio Health Research Institute | Columbus | Ohio |
United States | Baylor Scott & White Research Institute | Dallas | Texas |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Houston Methodist | Houston | Texas |
United States | Memorial Hermann - Texas Medical Center | Houston | Texas |
United States | Cedars Sinai Medical Center | Los Angeles | California |
United States | Methodist Le Bonheur Healthcare | Memphis | Tennessee |
United States | Minneapolis Heart Institute/ Abbott Northwestern | Minneapolis | Minnesota |
United States | New York-Presbyterian/ Columbia University Medical Center | New York | New York |
United States | Sentara Hospitals | Norfolk | Virginia |
United States | Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health | Oak Lawn | Illinois |
United States | Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital | Piscataway | New Jersey |
United States | Allegheny-Singer Health Network | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University | Portland | Oregon |
United States | Barnes-Jewish Hospital / Washington University | Saint Louis | Missouri |
United States | Intermountain Medical Center Heart Institute | Salt Lake City | Utah |
United States | Scripps Hospital | San Diego | California |
United States | California Pacific Medical Center Research Institute | San Francisco | California |
United States | University of Washington | Seattle | Washington |
United States | TMC HealthCare & PIMA Heart | Tucson | Arizona |
United States | MedStar Washington Hospital Center | Washington | District of Columbia |
United States | Lankenau | Wynnewood | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
JenaValve Technology, Inc. |
United States,
Geyer M, Tamm AR, Münzel 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. — View Citation
Iung B, Baron G, Butchart EG, Delahaye F, Gohlke-Bärwolf 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. — 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. Review. — 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
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All-Cause Mortality at 1 Year | All-cause mortality within the first 12 months post index procedure | 1 year | |
Primary | All Stroke | Number of patients that had a stroke | 30 days | |
Primary | Major Bleeding | Number of patients that had any of these events | 30 days | |
Primary | Acute Kidney Injury | Number of patients that had these events | 30 days | |
Primary | Major Vascular Complications | Number of patients that had these events | 30 days | |
Primary | Surgery/intervention related to the device | Number of patients that had these events | 30 days | |
Primary | Permanent pacemaker implantation | Number of patients that had these events | 30 days | |
Primary | Total aortic regurgitation | Number of patients that had these events | 30 days | |
Secondary | KCCQ | KCCQ Improvement | 1 year |
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