JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Cardiovascular Diseases Clinical Trial

Official title:

JENAVALVE ALIGN-AS TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Stenosis (AS)

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
• 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
• 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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases
• Constriction, Pathologic
• Heart Diseases
• Heart Valve Diseases
• Ventricular Outflow Obstruction

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