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THE ALIGN-AS EFS TRIAL: JenaValve 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
Last Update Posted : November 24, 2020
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)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: THE 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 : February 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2025

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 at 30 Days [ Time Frame: 30 days ]
    All-cause mortality rate at 30 days


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 5 years ]
    All cause mortality and cardiovascular mortality

  2. Myocardial Infarction [ Time Frame: up to 5 years ]
    Peri-procedural and spontaneous myocardial infarction

  3. Neurological Complications [ Time Frame: up to 5 years ]
    TIA and stroke

  4. Bleeding & Vascular Complications [ Time Frame: up to 5 years ]
    Major and minor bleeding



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, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Germany
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Universitätsklinikum Halle
Halle (Saale), Germany, 6120
Universitäres Herzzentrum Hamburg
Hamburg, Germany, 20246
Herzzentrum der Universität zu Köln
Köln, Germany, 50937
Netherlands
Leiden University Medical Center
Leiden, Netherlands, 2333
St. Antonius Hospital
Nieuwegein, Netherlands, 3435
Erasmus University Medical Center
Rotterdam, Netherlands, 3062
New Zealand
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 Vahl, MD New York-Presbyterian Hospital/Columbia University Medical Center, USA
Principal Investigator: Vinod Thourani, MD Emory University School of Medicine, USA
Principal Investigator: Hendrik Treede, MD University Hospital Bonn, Germany
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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
Last Update Posted: November 24, 2020
Last Verified: November 2020
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