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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04415047
Other study ID # P02C320
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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