JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

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)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Heart Diseases; Cardiovascular Diseases; Aortic Valve Stenosis; Heart Valve Diseases; Ventricular Outflow Obstruction
• Intervention / Treatment: Device: JenaValve Pericardial TAVR System

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Deutsches Herzzentrum Berlin
  • Freiburg, Germany, 79106
    • Universitäts-Herzzentrum Freiburg/Bad Krozingen
  • Halle (Saale), Germany, 6120
    • Universitatsklinikum Halle
  • Hamburg, Germany, 20246
    • Universitäres Herzzentrum Hamburg
  • Köln, Germany, 50937
    • Herzzentrum der Universität zu Köln
  • Stuttgart, Germany, 70376
    • Robert-Bosch-Krankenhaus
• Netherlands
  • Leiden, Netherlands, 2333
    • Leiden University Medical Center
  • Nieuwegein, Netherlands, 3435
    • St. Antonius Hospital
  • Rotterdam, Netherlands, 3062
    • Erasmus University Medical Center
• New Zealand
  • Auckland, New Zealand, 1142
    • Auckland City Hospital
  • Hamilton, New Zealand, 3240
    • Waikato Hospital
• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcatheter Aortic Valve Replacement (TAVR); Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.	Device: JenaValve Pericardial TAVR System; Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Mortality	All-cause mortality rate at 30 Day	30 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Myocardial Infarction	Peri-procedural and spontaneous myocardial infarction	30 Day
All Stroke/TIA	Neurological Complications	30 Day
Major Bleeding	Life threatening or major bleeding	30 Day
Major Vascular Complication	Major vascular and bleeding complications	30 Day
Conduction Disturbance and Arrhythmias	Conduction system injury (defect), including AV block, which may require a permanent pacemaker	30 Day
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
Coronary Obstruction Requiring Intervention	Coronary obstruction post-implant requiring intervention	30 Day
Endocarditis	Bacterial endocarditis	30 Day
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
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

Collaborators and Investigators

• Sponsor: JenaValve Technology, Inc.
• Investigators: Study Chair: Martin B Leon, MD, New York-Presbyterian Hospital/Columbia University Medical Center, USA; Principal Investigator: Torsten P Vahl, MD, New York-Presbyterian Hospital/Columbia University Medical Center, USA; Principal Investigator: Vinod H Thourani, MD, Piedmont Heart Institute, USA; Principal Investigator: Hendrik Treede, MD, University Hospital Bonn, Germany

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2016
• Primary Completion (Actual): May 28, 2019
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: March 18, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 11, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Valvular Heart Disease; Critical/Severe Aortic Stenosis; High risk symptomatic patients
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Diseases; Cardiovascular Diseases; Aortic Valve Stenosis; Constriction, Pathologic; Heart Valve Diseases; Ventricular Outflow Obstruction
• Other Study ID Numbers: CP-0003; P02C220_JV06EFS_CIP (Other Identifier: JenaValve Technology Inc.); CA-0001 EU (Other Identifier: JenaValve Technology Inc.); CA-0001 Germany (Other Identifier: JenaValve Technology Inc.); CA-0010 (Other Identifier: JenaValve Technology Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No