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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02732691
Other study ID # CP-0003
Secondary ID P02C220_JV06EFS_
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date October 21, 2016
Est. completion date April 2024

Study information

Verified date October 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 severe aortic stenosis (AS), which affects the aortic valve in the heart. Aortic stenosis is a narrowing of the aortic valve opening, which decreases blood flow from the heart and causes symptoms such as chest pain, fainting and shortness of breath. The preferred treatment for severe aortic stenosis is aortic valve replacement surgery.


Description:

This study will examine the use of a TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. This less invasive surgical approach called TAVR is offered to those patients who are high risk for undergoing open heart surgery to replace the aortic valve. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 68
Est. completion date April 2024
Est. primary completion date May 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient with severe degenerative native aortic stenosis (AS). - Patient at high risk for open surgical valve replacement - Patient symptomatic according to NYHA functional class II or higher 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

Study Design


Intervention

Device:
JenaValve Pericardial TAVR System
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

Locations

Country Name City State
Germany Deutsches Herzzentrum Berlin Berlin
Germany Universitäts-Herzzentrum Freiburg/Bad Krozingen Freiburg
Germany Universitätsklinikum Halle Halle (Saale)
Germany Universitäres Herzzentrum Hamburg Hamburg
Germany Herzzentrum der Universität zu Köln Köln
Germany Robert-Bosch-Krankenhaus Stuttgart
Netherlands Leiden University Medical Center Leiden
Netherlands St. Antonius Hospital Nieuwegein
Netherlands Erasmus University Medical Center Rotterdam
New Zealand Auckland City Hospital Auckland
New Zealand Waikato Hospital Hamilton
United States Columbia University Medical Center New York New York
United States MedStar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
JenaValve Technology, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Netherlands,  New Zealand, 

References & Publications (4)

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. — 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

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

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 All-cause mortality rate at 30 Day 30 Day
Secondary Myocardial Infarction Peri-procedural and spontaneous myocardial infarction 30 Day
Secondary All Stroke/TIA Neurological Complications 30 Day
Secondary Major Bleeding Life threatening or major bleeding 30 Day
Secondary Major Vascular Complication Major vascular and bleeding complications 30 Day
Secondary Conduction Disturbance and Arrhythmias Conduction system injury (defect), including AV block, which may require a permanent pacemaker 30 Day
Secondary Acute Kidney Injury (AKI) Number of patients who were diagnosed with AKI Stage 2 or 3:
AKI Stage 2: Increase in serum creatinine to 200%-299% (2.0%-2.99% increase compared with baseline) OR urine output <0.5 mL/kg/h for >12 but <24 h
AKI Stage 3: Increase in serum creatinine to =300% (>3 × increase compared with baseline) OR serum creatinine of =4.0 mg/dL (=354 mmol/L) with an acute increase of at least 0.5 mg/dL (44 mmol/L) OR urine output <0.3 ml/kg/h for =24 h OR anuria for =12 h
30 Day
Secondary Coronary Obstruction Requiring Intervention Coronary obstruction post-implant requiring intervention 30 Day
Secondary Endocarditis Bacterial endocarditis 30 Day
Secondary Conversion to Surgical Aortic Valve Replacement (SAVR) Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications 30 Day
Secondary THV Malpositioning Number of patients who experienced:
Migration: After initial correct positioning, the valve prosthesis moves upwards or downwards, within the aortic annulus from its initial position, with or without consequences
Embolization: The valve prosthesis moves during or after deployment such that it loses contact with the aortic annulus
Ectopic Valve Deployment: Permanent deployment of the valve prosthesis in a location other than the aortic root
30 Day
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