The JenaValve ALIGN-AR Pivotal Trial

NCT04415047 | Active Not Recruiting DMC FDA Device

• 1 other identifier: P02C320
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Aortic Regurgitation; Aortic Valve Insufficiency; Aortic Insufficiency; Aortic Valve Disease

Keywords

Valvular Heart Disease; Aortic Incompetence; Aortic Valve Incompetence

Outcome Measures

Primary Outcomes (8)

• 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

Secondary Outcomes (1)

• KCCQ

  1 year

Study Arms (1)

Transcatheter Aortic Valve Replacement (TAVR)

EXPERIMENTAL

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

Device: JenaValve Trilogy Heart Valve System

Interventions

JenaValve Trilogy Heart Valve System DEVICE

TAVR with JenaValve Trilogy Heart Valve System

Transcatheter Aortic Valve Replacement (TAVR)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• JenaValve Technology, Inc.: lead

Study Sites (30)

TMC HealthCare & PIMA Heart

Tucson, Arizona, 85712, United States

Location

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Scripps Hospital

San Diego, California, 92121, United States

Location

California Pacific Medical Center Research Institute

San Francisco, California, 94109, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Morton Plant/ BayCare Health

Clearwater, Florida, 33756, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health

Oak Lawn, Illinois, 60453, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Minneapolis Heart Institute/ Abbott Northwestern

Minneapolis, Minnesota, 55407, United States

Location

Barnes-Jewish Hospital / Washington University

St Louis, Missouri, 63110, United States

Location

Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital

Piscataway, New Jersey, 08901, United States

Location

New York-Presbyterian/ Columbia University Medical Center

New York, New York, 10032, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Allegheny-Singer Health Network

Pittsburgh, Pennsylvania, 15212, United States

Location

Lankenau

Wynnewood, Pennsylvania, 19096, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Methodist Le Bonheur Healthcare

Memphis, Tennessee, 38104, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75201, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Memorial Hermann - Texas Medical Center

Houston, Texas, 77030, United States

Location

Intermountain Medical Center Heart Institute

Salt Lake City, Utah, 84111, United States

Location

Sentara Hospitals

Norfolk, Virginia, 23502, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (9)

• 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.

  PMID: 28314623 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.

  PMID: 28298458 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.

  PMID: 12831818 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.

  PMID: 35568645 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.

  PMID: 34647465 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.

  PMID: 34317595 BACKGROUND

• 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.

  PMID: 41260228 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.

  PMID: 38552656 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.

  PMID: 34556282 DERIVED

MeSH Terms

Conditions

Aortic Valve Insufficiency; Aortic Valve Disease; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 4, 2020
• Study Start: May 22, 2020
• Primary Completion: August 29, 2023
• Study Completion (Estimated): August 1, 2028
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (30)