THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
NCT ID: NCT02732704
Last Updated: 2022-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2018-04-20
2027-09-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Transcatheter Aortic Valve Replacement (TAVR)
TAVR with JenaValve Pericardial Valve and Delivery System
JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System
Interventions
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JenaValve Pericardial TAVR System
TAVR with JenaValve Pericardial Valve and Delivery System
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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JenaValve Technology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin B. Leon, MD
Role: STUDY_CHAIR
New York-Presbyterian/ Columbia University Medical Center
Torsten P. Vahl, MD
Role: PRINCIPAL_INVESTIGATOR
New York-Presbyterian/ Columbia University Medical Center
Vinod H. Thourani, MD
Role: PRINCIPAL_INVESTIGATOR
Piedmont Healthcare
Stephan Baldus, MD
Role: PRINCIPAL_INVESTIGATOR
Herzzentrum der Universität zu Köln
Locations
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Cedars Sinai Medical Center
Los Angeles, California, United States
California Pacific Medical Center Research Institute
San Francisco, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Piedmont Healthcare
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
New York-Presbyterian/ Columbia University Medical Center
New York, New York, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Kerckhoff-Klinik GmbH Bad Nauheim
Bad Nauheim, , Germany
Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
Bad Oeynhausen, , Germany
Deutsches Herzzentrum Berlin
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , Germany
Herzzentrum der Universität zu Köln
Cologne, , Germany
Universitätsklinikum Frankfurt
Frankfurt, , Germany
Universitäres Herzzentrum Hamburg
Hamburg, , Germany
Leiden University Medical Center
Leiden, , Netherlands
St. Antonius Hospital
Nieuwegein, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Countries
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References
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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.
Other Identifiers
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P02C320_JV06EFS_CIP
Identifier Type: OTHER
Identifier Source: secondary_id
CA-0002 EU
Identifier Type: OTHER
Identifier Source: secondary_id
CA-0002 Germany
Identifier Type: OTHER
Identifier Source: secondary_id
CA-0011
Identifier Type: OTHER
Identifier Source: secondary_id
CP-0004
Identifier Type: -
Identifier Source: org_study_id
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