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JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

Primary Purpose

Aortic Valve Stenosis, Heart Valve Diseases, Heart Diseases

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
JenaValve Pericardial TAVR System
Sponsored by
JenaValve Technology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Valvular Heart Disease, Critical/Severe Aortic Stenosis, High risk symptomatic patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MedStar Washington Hospital Center
  • Columbia University Medical Center
  • Deutsches Herzzentrum Berlin
  • Universitäts-Herzzentrum Freiburg/Bad Krozingen
  • Universitätsklinikum Halle
  • Universitäres Herzzentrum Hamburg
  • Herzzentrum der Universität zu Köln
  • Robert-Bosch-Krankenhaus
  • Leiden University Medical Center
  • St. Antonius Hospital
  • Erasmus University Medical Center
  • Auckland City Hospital
  • Waikato Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transcatheter Aortic Valve Replacement (TAVR)

Arm Description

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

Outcomes

Primary Outcome Measures

All-Cause Mortality
All-cause mortality rate at 30 Day

Secondary Outcome Measures

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

Full Information

First Posted
March 18, 2016
Last Updated
October 28, 2022
Sponsor
JenaValve Technology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02732691
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2016 (Actual)
Primary Completion Date
May 28, 2019 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JenaValve Technology, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcatheter Aortic Valve Replacement (TAVR)
Arm Type
Experimental
Arm Description
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Intervention Type
Device
Intervention Name(s)
JenaValve Pericardial TAVR System
Intervention Description
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
Primary Outcome Measure Information:
Title
All-Cause Mortality
Description
All-cause mortality rate at 30 Day
Time Frame
30 Day
Secondary Outcome Measure Information:
Title
Myocardial Infarction
Description
Peri-procedural and spontaneous myocardial infarction
Time Frame
30 Day
Title
All Stroke/TIA
Description
Neurological Complications
Time Frame
30 Day
Title
Major Bleeding
Description
Life threatening or major bleeding
Time Frame
30 Day
Title
Major Vascular Complication
Description
Major vascular and bleeding complications
Time Frame
30 Day
Title
Conduction Disturbance and Arrhythmias
Description
Conduction system injury (defect), including AV block, which may require a permanent pacemaker
Time Frame
30 Day
Title
Acute Kidney Injury (AKI)
Description
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
Time Frame
30 Day
Title
Coronary Obstruction Requiring Intervention
Description
Coronary obstruction post-implant requiring intervention
Time Frame
30 Day
Title
Endocarditis
Description
Bacterial endocarditis
Time Frame
30 Day
Title
Conversion to Surgical Aortic Valve Replacement (SAVR)
Description
Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications
Time Frame
30 Day
Title
THV Malpositioning
Description
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
Time Frame
30 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin B Leon, MD
Organizational Affiliation
New York-Presbyterian Hospital/Columbia University Medical Center, USA
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Torsten P Vahl, MD
Organizational Affiliation
New York-Presbyterian Hospital/Columbia University Medical Center, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vinod H Thourani, MD
Organizational Affiliation
Piedmont Heart Institute, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hendrik Treede, MD
Organizational Affiliation
University Hospital Bonn, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Deutsches Herzzentrum Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg/Bad Krozingen
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsklinikum Halle
City
Halle (Saale)
ZIP/Postal Code
6120
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Herzzentrum der Universität zu Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333
Country
Netherlands
Facility Name
St. Antonius Hospital
City
Nieuwegein
ZIP/Postal Code
3435
Country
Netherlands
Facility Name
Erasmus University Medical Center
City
Rotterdam
ZIP/Postal Code
3062
Country
Netherlands
Facility Name
Auckland City Hospital
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
Waikato Hospital
City
Hamilton
ZIP/Postal Code
3240
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28314623
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.
Results Reference
background
PubMed Identifier
28298458
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.
Results Reference
background
PubMed Identifier
12831818
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.
Results Reference
background
PubMed Identifier
34556282
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.
Results Reference
background

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JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

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