Clinical trial NCT02732691: JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Keywords: Valvular Heart Disease
Critical/Severe Aortic Stenosis
High risk symptomatic patients
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: All-Cause Mortality
timeFrame: 30 Day
Secondary outcomes:
measure: Myocardial Infarction
timeFrame: 30 Day
measure: All Stroke/TIA
timeFrame: 30 Day
measure: Major Bleeding
timeFrame: 30 Day
measure: Major Vascular Complication
timeFrame: 30 Day
measure: Conduction Disturbance and Arrhythmias
timeFrame: 30 Day
measure: Acute Kidney Injury (AKI)
timeFrame: 30 Day
measure: Coronary Obstruction Requiring Intervention
timeFrame: 30 Day
measure: Endocarditis
timeFrame: 30 Day
measure: Conversion to Surgical Aortic Valve Replacement (SAVR)
timeFrame: 30 Day
measure: THV Malpositioning
timeFrame: 30 Day
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg/Bad Krozingen
city: Halle (Saale)
country: Germany
facility: Universitätsklinikum Halle
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Köln
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Stuttgart
country: Germany
facility: Robert-Bosch-Krankenhaus
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
Study officials:
affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, USA
name: Martin B Leon, MD
role: STUDY_CHAIR
affiliation: New York-Presbyterian Hospital/Columbia University Medical Center, USA
name: Torsten P Vahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Heart Institute, USA
name: Vinod H Thourani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Bonn, Germany
name: Hendrik Treede, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. No abstract available.
citation: 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.
citation: 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.