The JenaValve ALIGN-AR Pivotal Trial (ALIGN-AR)

• ClinicalTrials.gov Identifier: NCT04415047
• Recruitment Status: Active, not recruiting
• First Posted: June 4, 2020
• Last Update Posted: September 13, 2022
• Sponsor: JenaValve Technology, Inc.
• Information provided by (Responsible Party): JenaValve Technology, Inc.

Tracking Information

• First Submitted Date: May 31, 2020
• First Posted Date: June 4, 2020
• Last Update Posted Date: September 13, 2022
• Actual Study Start Date: May 22, 2020
• Estimated Primary Completion Date: August 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 20, 2021)

• All-Cause Mortality at 1 Year [ Time Frame: 1 year ]
  All-cause mortality within the first 12 months post index procedure
• All Stroke [ Time Frame: 30 days ]
  Number of patients that had a stroke
• Major Bleeding [ Time Frame: 30 days ]
  Number of patients that had any of these events
• Acute Kidney Injury [ Time Frame: 30 days ]
  Number of patients that had these events
• Major Vascular Complications [ Time Frame: 30 days ]
  Number of patients that had these events
• Surgery/intervention related to the device [ Time Frame: 30 days ]
  Number of patients that had these events
• Permanent pacemaker implantation [ Time Frame: 30 days ]
  Number of patients that had these events
• Total aortic regurgitation [ Time Frame: 30 days ]
  Number of patients that had these events

Original Primary Outcome Measures (submitted: May 31, 2020)

All-Cause Mortality at 6 Months [ Time Frame: 6 Months ]

All-Cause mortality within the first 6 months post index procedure

Current Secondary Outcome Measures (submitted: August 20, 2021)

KCCQ [ Time Frame: 1 year ]

KCCQ Improvement

Original Secondary Outcome Measures (submitted: May 31, 2020)

• Mortality [ Time Frame: 30 days ]
  Absence of procedural mortality
• Myocardial Infarction [ Time Frame: 30 days ]
  Peri-procedural and spontaneous myocardial infarction
• Neurological Complications [ Time Frame: 30 days ]
  Disabling or non-disabling stroke
• Bleeding & Vascular Complications [ Time Frame: 30 days ]
  Major and minor bleeding

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The JenaValve ALIGN-AR Pivotal Trial
• 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)
• 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

Device: JenaValve Trilogy Heart Valve System

TAVR with JenaValve Trilogy Heart Valve System

Study Arms

Experimental: Transcatheter Aortic Valve Replacement (TAVR)

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

Intervention: Device: JenaValve Trilogy Heart Valve System

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: August 20, 2021): 180
• Original Estimated Enrollment (submitted: May 31, 2020): 50
• Estimated Study Completion Date: August 2028
• Estimated Primary Completion Date: August 29, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04415047
• Other Study ID Numbers: P02C320
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: JenaValve Technology, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: JenaValve Technology, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Martin B. Leon, MD; New York-Presbyterian/ Columbia University Medical Center
• Principal Investigator: Torsten P. Vahl, MD; New York-Presbyterian/ Columbia University Medical Center
• Principal Investigator: Vinod H. Thourani, MD; Piedmont Healthcare

• PRS Account: JenaValve Technology, Inc.
• Verification Date: September 2022