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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.
This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat symptomatic severe aortic regurgitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcatheter Aortic Valve Replacement (TAVR) | Experimental | TAVR with JenaValve Trilogy Heart Valve System Intervention Device: JenaValve Trilogy Heart Valve System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JenaValve Trilogy Heart Valve System | Device | TAVR with JenaValve Trilogy Heart Valve System |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Mortality at 1 Year | All-cause mortality within the first 12 months post index procedure | 1 year |
| All Stroke | Number of patients that had a stroke | 30 days |
| Major Bleeding | Number of patients that had any of these events | 30 days |
| Acute Kidney Injury | Number of patients that had these events | 30 days |
| Major Vascular Complications | Number of patients that had these events | 30 days |
| Surgery/intervention related to the device | Number of patients that had these events | 30 days |
| Permanent pacemaker implantation | Number of patients that had these events | 30 days |
| Total aortic regurgitation | Number of patients that had these events | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| KCCQ | KCCQ Improvement | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin B. Leon, MD | New York-Presbyterian/ Columbia University Medical Center | Study Chair |
| Torsten P. Vahl, MD | New York-Presbyterian/ Columbia University Medical Center | Principal Investigator |
| Vinod H. Thourani, MD | Piedmont Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TMC HealthCare & PIMA Heart | Tucson | Arizona | 85712 | United States | ||
| Cedars Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28314623 | Background | 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. | |
| 28298458 |
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| Los Angeles |
| California |
| 90048 |
| United States |
| Scripps Hospital | San Diego | California | 92121 | United States |
| California Pacific Medical Center Research Institute | San Francisco | California | 94109 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Morton Plant/ BayCare Health | Clearwater | Florida | 33756 | United States |
| Piedmont Healthcare | Atlanta | Georgia | 30309 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health | Oak Lawn | Illinois | 60453 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Minneapolis Heart Institute/ Abbott Northwestern | Minneapolis | Minnesota | 55407 | United States |
| Barnes-Jewish Hospital / Washington University | St Louis | Missouri | 63110 | United States |
| Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital | Piscataway | New Jersey | 08901 | United States |
| New York-Presbyterian/ Columbia University Medical Center | New York | New York | 10032 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio Health Research Institute | Columbus | Ohio | 43214 | United States |
| Oregon Health & Science University | Portland | Oregon | 97239 | United States |
| Allegheny-Singer Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| Lankenau | Wynnewood | Pennsylvania | 19096 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Methodist Le Bonheur Healthcare | Memphis | Tennessee | 38104 | United States |
| Baylor Scott & White Research Institute | Dallas | Texas | 75201 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| Memorial Hermann - Texas Medical Center | Houston | Texas | 77030 | United States |
| Intermountain Medical Center Heart Institute | Salt Lake City | Utah | 84111 | United States |
| Sentara Hospitals | Norfolk | Virginia | 23502 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Background |
| 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. |
| 12831818 | Background | 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. |
| 35568645 | Background | 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. |
| 34647465 | Background | 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. |
| 34317595 | Background | 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. |
| 41928824 | Derived | Tang RS, Li YM, Bao Y, Zeng JD, Yao YJ, Wang JY, Yang XY, Xu YJ, Pu XZ, Jiang WL, Jia YH, Yin Y, Li H, Li W, Yi Z, Chen M. Development of a multi-label deep neural network model for predicting immediate paravalvular leakage and new-onset conduction disturbances after transcatheter aortic valve replacement: A retrospective cohort study. Digit Health. 2026 Mar 31;12:20552076261427502. doi: 10.1177/20552076261427502. eCollection 2026 Jan-Dec. |
| 41260228 | Derived | Makkar RR, Thourani VH, Vahl TP, Yadav PK, McCabe JM, George I, Satler L, Chetcuti S, Daniels DV, Waggoner T, Whisenant B, Russo M, Summers M, Garcia S, Frisoli T, Ramana RK, Stinis C, Golwala H, Zahr F, Greenbaum A, Rovin J, Sanchez C, Szerlip M, Deeb GM, Amoroso N, Patel D, Fahy M, Ranard LS, Gupta A, Chakravarty T, Skaf S, Chuang M, Kodali SK, Figulla HR, Treede H, Baldus S, Pinto DS, Leon MB; ALIGN-AR Investigators. Transcatheter aortic valve implantation with the Trilogy valve for symptomatic native aortic regurgitation (ALIGN-AR): a pivotal, multicentre, single-arm, investigational device exemption study. Lancet. 2025 Dec 13;406(10521):2757-2771. doi: 10.1016/S0140-6736(25)02215-9. Epub 2025 Nov 16. |
| 38552656 | Derived | 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. |
| 34556282 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 29, 2025 | Sep 17, 2025 | 9 | ||
| Sep 26, 2025 | Oct 14, 2025 | 10 | ||
| Mar 31, 2026 | Apr 21, 2026 | 11 |
| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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