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Active, Not Recruiting

NCT Number: NCT04415047

The JenaValve ALIGN-AR Pivotal Trial

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Aortic Regurgitation Aortic Insufficiency Aortic Valve Disease Aortic Valve Insufficiency Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TMC HealthCare & PIMA Heart, Tucson, Arizona, United States

Loading trial locations.

About this study

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 symptomatic severe aortic regurgitation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JenaValve Trilogy Heart Valve System

Device

TAVR with JenaValve Trilogy Heart Valve System

Primary outcomes

  1. All-Cause Mortality at 1 Year

    Time frame: 1 year

    All-cause mortality within the first 12 months post index procedure

  2. All Stroke

    Time frame: 30 days

    Number of patients that had a stroke

  3. Major Bleeding

    Time frame: 30 days

    Number of patients that had any of these events

  4. Acute Kidney Injury

    Time frame: 30 days

    Number of patients that had these events

  5. Major Vascular Complications

    Time frame: 30 days

    Number of patients that had these events

  6. Surgery/intervention related to the device

    Time frame: 30 days

    Number of patients that had these events

  7. Permanent pacemaker implantation

    Time frame: 30 days

    Number of patients that had these events

  8. Total aortic regurgitation

    Time frame: 30 days

    Number of patients that had these events

Secondary outcomes

  1. KCCQ

    Time frame: 1 year

    KCCQ Improvement

Sponsors and collaborators

Lead sponsor

JenaValve Technology, Inc.

Industry

Registry information

Official study title

A Study to Assess Safety and Effectiveness of the JenaValve Trilogy™ Heart Valve System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR)

Acronym: ALIGN-AR

Important dates

Study start
2020
Primary completion
2023
Study completion
2028
First posted
Jun 4, 2020
Registry last updated
Sep 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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