THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
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)
5 other identifiers
interventional
100
3 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2016
CompletedFirst Posted
Study publicly available on registry
April 11, 2016
CompletedStudy Start
First participant enrolled
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 29, 2027
ExpectedNovember 18, 2022
November 1, 2022
4.4 years
March 18, 2016
November 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
All-Cause Mortality at 30 days
All-Cause mortality within the first 30 days post index procedure
30 days
Secondary Outcomes (4)
Mortality
At 30 days
Peri-Procedural Myocardial Infarction
At ≤72hr after the index procedure
Stroke-Free Survival
At 30 days and 1 year
Bleeding & Vascular Complications
30 days
Study Arms (1)
Transcatheter Aortic Valve Replacement (TAVR)
EXPERIMENTALTAVR with JenaValve Pericardial Valve and Delivery System
Interventions
TAVR with JenaValve Pericardial Valve and Delivery System
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
California Pacific Medical Center Research Institute
San Francisco, California, 94109, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
New York-Presbyterian/ Columbia University Medical Center
New York, New York, 10032, United States
Baylor Scott & White Research Institute
Dallas, Texas, 75201, United States
University of Washington
Seattle, Washington, 98195, United States
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, 61231, Germany
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, 32545, Germany
Deutsches Herzzentrum Berlin
Berlin, 13353, Germany
Universitätsklinikum Bonn
Bonn, 53127, Germany
Herzzentrum der Universität zu Köln
Cologne, 50937, Germany
Universitätsklinikum Frankfurt
Frankfurt, 60323, Germany
Universitäres Herzzentrum Hamburg
Hamburg, 20246, Germany
Leiden University Medical Center
Leiden, 2333, Netherlands
St. Antonius Hospital
Nieuwegein, 3435, Netherlands
Erasmus University Medical Center
Rotterdam, 3062, Netherlands
Related Publications (1)
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.
PMID: 34556282DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2016
First Posted
April 11, 2016
Study Start
April 20, 2018
Primary Completion
August 29, 2022
Study Completion (Estimated)
September 29, 2027
Last Updated
November 18, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share