Clinical trial NCT02732704: THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Aortic Regurgitation
Keywords: Aortic Valve Disease
Aortic Regurgitation
Aortic Insufficiency
Lead sponsor: JenaValve Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All-Cause Mortality at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: At 30 days
measure: Peri-Procedural Myocardial Infarction
timeFrame: At ≤72hr after the index procedure
measure: Stroke-Free Survival
timeFrame: At 30 days and 1 year
measure: Bleeding & Vascular Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center Research Institute
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: New York-Presbyterian/ Columbia University Medical Center
state: New York
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH Bad Nauheim
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW Ruhr-Universität Bochum Bad Oeynhausen
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Köln
country: Germany
facility: Herzzentrum der Universität zu Köln
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nieuwegein
country: Netherlands
facility: St. Antonius Hospital
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
Study officials:
affiliation: New York-Presbyterian/ Columbia University Medical Center
name: Martin B. Leon, MD
role: STUDY_CHAIR
affiliation: New York-Presbyterian/ Columbia University Medical Center
name: Torsten P. Vahl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Piedmont Healthcare
name: Vinod H. Thourani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Herzzentrum der Universität zu Köln
name: Stephan Baldus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.