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THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation 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: NCT02732704
Recruitment Status : Active, not recruiting
First Posted : April 11, 2016
Last Update Posted : November 18, 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 November 18, 2022
Actual Study Start Date  ICMJE April 20, 2018
Actual Primary Completion Date August 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2020)
All-Cause Mortality at 30 days [ Time Frame: 30 days ]
All-Cause mortality within the first 30 days post index procedure
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2020)
  • Mortality [ Time Frame: At 30 days ]
    Absence of procedural mortality
  • Peri-Procedural Myocardial Infarction [ Time Frame: At ≤72hr after the index procedure ]
    Peri-procedural and spontaneous myocardial infarction
  • Stroke-Free Survival [ Time Frame: At 30 days and 1 year ]
    Disabling or non-disabling stroke
  • Bleeding & Vascular Complications [ Time Frame: 30 days ]
    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-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
Official Title  ICMJE THE ALIGN-AR TRIAL: Safety and Effectiveness/Performance of the Transfemoral JenaValve Pericardial TAVR System in the Treatment of Patients With Symptomatic Severe Aortic Regurgitation (AR)
Brief Summary To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.
Detailed Description This study will examine the use of TAVR (Transcatheter Aortic Valve Replacement), which is a minimally invasive procedure designed to replace the aortic valve inside the heart. In this study, TAVR will be performed using the JenaValve Pericardial TAVR System, which is intended to help treat severe aortic regurgitation.
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 Regurgitation
Intervention  ICMJE Device: JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System
Study Arms  ICMJE Experimental: Transcatheter Aortic Valve Replacement (TAVR)
TAVR with 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. No abstract available.

*   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: July 30, 2021)
100
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 29, 2027
Actual Primary Completion Date August 29, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with severe aortic regurgitation (AR).
  • Patient at high risk for open surgical valve replacement
  • Patient symptomatic according to NYHA functional class II or higher
  • The study patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board (IRB)/ Ethics Committee (EC) of the respective clinical site.

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
  • Severe mitral regurgitation
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,   United States
Removed Location Countries New Zealand
 
Administrative Information
NCT Number  ICMJE NCT02732704
Other Study ID Numbers  ICMJE CP-0004
P02C320_JV06EFS_CIP ( Other Identifier: JenaValve Technology Inc. )
CA-0002 EU ( Other Identifier: JenaValve Technology Inc. )
CA-0002 Germany ( Other Identifier: JenaValve Technology Inc. )
CA-0011 ( Other Identifier: JenaValve Technology Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
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/ Columbia University Medical Center
Principal Investigator: Torsten P. Vahl, MD New York-Presbyterian/ Columbia University Medical Center
Principal Investigator: Vinod H. Thourani, MD Piedmont Healthcare
Principal Investigator: Stephan Baldus, MD Herzzentrum der Universität zu Köln
PRS Account JenaValve Technology, Inc.
Verification Date November 2022

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