The JenaValve ALIGN-AR Pivotal Trial

Aortic Valve Disease Clinical Trial

— ALIGN-AR  

Official 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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04415047
• Other study ID #: P02C320
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 22, 2020
• Est. completion date: August 2028

Study information

• Verified date: September 2022
• Source: JenaValve Technology, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Aortic Insufficiency
• Aortic Regurgitation
• Aortic Valve Disease
• Aortic Valve Insufficiency

Intervention

Device:
• JenaValve Trilogy Heart Valve System
TAVR with JenaValve Trilogy Heart Valve System

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
JenaValve Technology, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

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