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Clinical Trials in the USA / NCT04415047
Active, not recruiting Not applicable

The JenaValve ALIGN-AR Pivotal Trial

NCT04415047 · tracked via the Priya Life Science USA tracker
Sponsor
JenaValve Technology, Inc
Phase
Not applicable
Started
2020-05-22
Last updated
2022-09-13

Condition(s) studied

Aortic RegurgitationAortic Valve InsufficiencyAortic InsufficiencyAortic Valve Disease

Investigational drug(s) / intervention(s)

JenaValve Trilogy Heart Valve System

JenaValve Trilogy Heart Valve System: TAVR with JenaValve Trilogy Heart Valve System

Study summary

To collect information about treatment for symptomatic 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • All-Cause Mortality at 1 Year — 1 year
    All-cause mortality within the first 12 months post index procedure
  • All Stroke — 30 days
    Number of patients that had a stroke
  • Major Bleeding — 30 days
    Number of patients that had any of these events
  • Acute Kidney Injury — 30 days
    Number of patients that had these events
  • Major Vascular Complications — 30 days
    Number of patients that had these events
  • Surgery/intervention related to the device — 30 days
    Number of patients that had these events
  • Permanent pacemaker implantation — 30 days
    Number of patients that had these events
  • Total aortic regurgitation — 30 days
    Number of patients that had these events

Trial sites (30)

FacilityCityRegionStatus
TMC HealthCare & PIMA Heart Tucson Arizona
Cedars Sinai Medical Center Los Angeles California
Scripps Hospital San Diego California
California Pacific Medical Center Research Institute San Francisco California
MedStar Washington Hospital Center Washington D.C. District of Columbia
Morton Plant/ BayCare Health Clearwater Florida
Piedmont Healthcare Atlanta Georgia
Emory University Hospital Atlanta Georgia
Cardiac Surgery Clinical Research Center Inc./ Advocate Aurora Health Oak Lawn Illinois
University of Maryland Medical Center Baltimore Maryland
University of Michigan Ann Arbor Michigan
Henry Ford Health System Detroit Michigan
Minneapolis Heart Institute/ Abbott Northwestern Minneapolis Minnesota
Barnes-Jewish Hospital / Washington University St Louis Missouri
Rutgers Robert Wood Johnson Medical School/ Rutgers Robert Wood University Hospital Piscataway New Jersey
New York-Presbyterian/ Columbia University Medical Center New York New York
The Christ Hospital Cincinnati Ohio
Cleveland Clinic Foundation Cleveland Ohio
Ohio Health Research Institute Columbus Ohio
Oregon Health & Science University Portland Oregon
Allegheny-Singer Health Network Pittsburgh Pennsylvania
Lankenau Wynnewood Pennsylvania
Medical University of South Carolina Charleston South Carolina
Methodist Le Bonheur Healthcare Memphis Tennessee
Baylor Scott & White Research Institute Dallas Texas
Houston Methodist Houston Texas
Memorial Hermann - Texas Medical Center Houston Texas
Intermountain Medical Center Heart Institute Salt Lake City Utah
Sentara Hospitals Norfolk Virginia
University of Washington Seattle Washington

More JenaValve Technology, Inc. trials in the USA

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ Recruiting
The JenaValve ALIGN-AR LVAD Registry Active, not recruiting
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study Active, not recruiting

Other trials for the same condition

ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ Recruiting
CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material Recruiting
J-Valve TF Early Feasibility Study Active, not recruiting
SJM Masters HP 15mm Rotatable Mechanical Heart Valve as Aortic Valve Replacement Therapy Active, not recruiting
Avalus Ultra Post-Approval Study (PAS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04415047 on ClinicalTrials.gov ↗ ← All trials in the USA