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JENAVALVE AS EFS TRIAL: Pericardial TAVR Aortic Stenosis Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02732691
Recruitment Status : Active, not recruiting
First Posted : April 11, 2016
Results First Posted : November 22, 2022
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology, Inc.

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.

Condition or disease Intervention/treatment Phase
Aortic Valve Stenosis Heart Valve Diseases Heart Diseases Cardiovascular Diseases Ventricular Outflow Obstruction Device: JenaValve Pericardial TAVR System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Actual Study Start Date : October 21, 2016
Actual Primary Completion Date : May 28, 2019
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. All-Cause Mortality [ Time Frame: 30 Day ]
    All-cause mortality rate at 30 Day


Secondary Outcome Measures :
  1. Myocardial Infarction [ Time Frame: 30 Day ]
    Peri-procedural and spontaneous myocardial infarction

  2. All Stroke/TIA [ Time Frame: 30 Day ]
    Neurological Complications

  3. Major Bleeding [ Time Frame: 30 Day ]
    Life threatening or major bleeding

  4. Major Vascular Complication [ Time Frame: 30 Day ]
    Major vascular and bleeding complications

  5. Conduction Disturbance and Arrhythmias [ Time Frame: 30 Day ]
    Conduction system injury (defect), including AV block, which may require a permanent pacemaker

  6. Acute Kidney Injury (AKI) [ Time Frame: 30 Day ]

    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


  7. Coronary Obstruction Requiring Intervention [ Time Frame: 30 Day ]
    Coronary obstruction post-implant requiring intervention

  8. Endocarditis [ Time Frame: 30 Day ]
    Bacterial endocarditis

  9. Conversion to Surgical Aortic Valve Replacement (SAVR) [ Time Frame: 30 Day ]
    Number of patients who underwent conversion to open sternotomy during the TAVR procedure secondary to any procedure-related complications

  10. THV Malpositioning [ Time Frame: 30 Day ]

    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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02732691


Locations
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United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Universitäts-Herzzentrum Freiburg/Bad Krozingen
Freiburg, Germany, 79106
Universitätsklinikum Halle
Halle (Saale), Germany, 6120
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Herzzentrum der Universität zu Köln
Köln, Germany, 50937
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333
St. Antonius Hospital
Nieuwegein, Netherlands, 3435
Erasmus University Medical Center
Rotterdam, Netherlands, 3062
New Zealand
Auckland City Hospital
Auckland, New Zealand, 1142
Waikato Hospital
Hamilton, New Zealand, 3240
Sponsors and Collaborators
JenaValve Technology, Inc.
Investigators
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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
  Study Documents (Full-Text)

Documents provided by JenaValve Technology, Inc.:
Publications:

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Responsible Party: JenaValve Technology, Inc.
ClinicalTrials.gov Identifier: NCT02732691    
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. )
First Posted: April 11, 2016    Key Record Dates
Results First Posted: November 22, 2022
Last Update Posted: November 22, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by JenaValve Technology, Inc.:
Valvular Heart Disease
Critical/Severe Aortic Stenosis
High risk symptomatic patients
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Aortic Valve Stenosis
Heart Valve Diseases
Ventricular Outflow Obstruction
Constriction, Pathologic
Pathological Conditions, Anatomical
Aortic Valve Disease