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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 : March 23, 2022
Sponsor:
Information provided by (Responsible Party):
JenaValve Technology, Inc.

Tracking Information
First Submitted Date  ICMJE March 18, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date March 23, 2022
Actual Study Start Date  ICMJE February 2016
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
All-Cause Mortality at 30 Days [ Time Frame: 30 days ]
All-cause mortality rate at 30 days
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2019)
  • Mortality [ Time Frame: up to 5 years ]
    All cause mortality and cardiovascular mortality
  • Myocardial Infarction [ Time Frame: up to 5 years ]
    Peri-procedural and spontaneous myocardial infarction
  • Neurological Complications [ Time Frame: up to 5 years ]
    TIA and stroke
  • Bleeding & Vascular Complications [ Time Frame: up to 5 years ]
    Major and minor bleeding
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE THE ALIGN-AS EFS TRIAL: JenaValve Pericardial TAVR Aortic Stenosis Study
Official Title  ICMJE 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)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Aortic Valve Stenosis
  • Heart Valve Diseases
  • Heart Diseases
  • Cardiovascular Diseases
  • Ventricular Outflow Obstruction
Intervention  ICMJE Device: JenaValve Pericardial TAVR System
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
Study Arms  ICMJE Experimental: Transcatheter Aortic Valve Replacement (TAVR)
Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve pericardial valve and delivery system.
Intervention: Device: JenaValve Pericardial TAVR System
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 4, 2018)
90
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE June 2025
Actual Primary Completion Date May 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Netherlands,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02732691
Other Study ID Numbers  ICMJE 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. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party JenaValve Technology, Inc.
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE JenaValve Technology, Inc.
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account JenaValve Technology, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP