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Active, not recruitingNCT02732704Updated Nov 18, 2022

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

An interventional study of JenaValve Pericardial TAVR System in Aortic Regurgitation, sponsored by JenaValve Technology, Inc.. Active, not recruiting at 19 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.

Sponsored by JenaValve Technology, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Aortic Regurgitation

Keywords

  • Aortic Valve Disease
  • Aortic Regurgitation
  • Aortic Insufficiency
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In context

Aortic Valve Insufficiency

162 studies on the registry are indexed under Aortic Valve Insufficiency; 52 are open to participants now.

This study's planned enrollment of 100 is below the median of 112 across 88 interventional studies indexed under Aortic Valve Insufficiency.

Browse Aortic Valve Insufficiency studies →

Lead sponsor

JenaValve Technology, Inc. is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Transcatheter Aortic Valve Replacement (TAVR)

    TAVR with JenaValve Pericardial Valve and Delivery System

    Device: JenaValve Pericardial TAVR System

Interventions

  • DeviceJenaValve Pericardial TAVR System

    TAVR with JenaValve Pericardial Valve and Delivery System

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What researchers measure

Primary outcomes

  1. All-Cause Mortality at 30 days

    All-Cause mortality within the first 30 days post index procedure

    Time frame: 30 days

Secondary outcomes

  1. Mortality

    Absence of procedural mortality

    Time frame: At 30 days

  2. Peri-Procedural Myocardial Infarction

    Peri-procedural and spontaneous myocardial infarction

    Time frame: At ≤72hr after the index procedure

  3. Stroke-Free Survival

    Disabling or non-disabling stroke

    Time frame: At 30 days and 1 year

  4. Bleeding & Vascular Complications

    Major and minor bleeding

    Time frame: 30 days

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Study locations

19 sites
  • 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, 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
  • Universitätsklinikum Frankfurt
    Frankfurt, 60323, Germany
  • Universitäres Herzzentrum Hamburg
    Hamburg, 20246, Germany
  • Herzzentrum der Universität zu Köln
    Köln, 50937, Germany
  • Leiden University Medical Center
    Leiden, 2333, Netherlands
  • St. Antonius Hospital
    Nieuwegein, 3435, Netherlands
  • Erasmus University Medical Center
    Rotterdam, 3062, Netherlands
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References and documents

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. PubMed 34556282 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02732704
Lead sponsor
JenaValve Technology, Inc.
Responsible party
Sponsor
First posted
Apr 11, 2016
Start date
Apr 20, 2018
Primary completion
Aug 29, 2022
Completion
Sep 29, 2027 (estimated)
Last update
Nov 18, 2022

Study contacts

Martin B. Leon, MD
study chair · New York-Presbyterian/ Columbia University Medical Center
Torsten P. Vahl, MD
principal investigator · New York-Presbyterian/ Columbia University Medical Center
Vinod H. Thourani, MD
principal investigator · Piedmont Healthcare
Stephan Baldus, MD
principal investigator · Herzzentrum der Universität zu Köln

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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