JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

NCT ID: NCT02732691

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-21
• Study Completion Date: 2024-04-30

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.

Conditions

Aortic Valve Stenosis; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transcatheter Aortic Valve Replacement (TAVR)

Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.

Group Type: EXPERIMENTAL

JenaValve Pericardial TAVR System

Intervention Type: DEVICE

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

Interventions

JenaValve Pericardial TAVR System

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JenaValve Technology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin B Leon, MD

Role: STUDY_CHAIR

New York-Presbyterian Hospital/Columbia University Medical Center, USA

Torsten P Vahl, MD

Role: PRINCIPAL_INVESTIGATOR

New York-Presbyterian Hospital/Columbia University Medical Center, USA

Vinod H Thourani, MD

Role: PRINCIPAL_INVESTIGATOR

Piedmont Heart Institute, USA

Hendrik Treede, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bonn, Germany

Locations

MedStar Washington Hospital Center

Washington D.C., District of Columbia, United States

Columbia University Medical Center

New York, New York, United States

Deutsches Herzzentrum Berlin

Berlin, , Germany

Herzzentrum der Universität zu Köln

Cologne, , Germany

Universitäts-Herzzentrum Freiburg/Bad Krozingen

Freiburg im Breisgau, , Germany

Universitätsklinikum Halle

Halle, , Germany

Universitäres Herzzentrum Hamburg

Hamburg, , Germany

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Leiden University Medical Center

Leiden, , Netherlands

St. Antonius Hospital

Nieuwegein, , Netherlands

Erasmus University Medical Center

Rotterdam, , Netherlands

Auckland City Hospital

Auckland, , New Zealand

Waikato Hospital

Hamilton, , New Zealand

Countries

United States; Germany; Netherlands; New Zealand

References

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.

Reference Type: BACKGROUND

PMID: 28314623 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28298458 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12831818 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34556282 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P02C220_JV06EFS_CIP

Identifier Type: OTHER

Identifier Source: secondary_id

CA-0001 EU

Identifier Type: OTHER

Identifier Source: secondary_id

CA-0001 Germany

Identifier Type: OTHER

Identifier Source: secondary_id

CA-0010

Identifier Type: OTHER

Identifier Source: secondary_id

CP-0003

Identifier Type: -

Identifier Source: org_study_id