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NCT Number: NCT02732704

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Aortic Regurgitation 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

Kerckhoff-Klinik GmbH Bad Nauheim, Bad Nauheim, Germany

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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 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 Pericardial TAVR System

Device

TAVR with JenaValve Pericardial Valve and Delivery System

Primary outcomes

  1. All-Cause Mortality at 30 days

    Time frame: 30 days

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

Secondary outcomes

  1. Mortality

    Time frame: At 30 days

    Absence of procedural mortality

  2. Peri-Procedural Myocardial Infarction

    Time frame: At ≤72hr after the index procedure

    Peri-procedural and spontaneous myocardial infarction

  3. Stroke-Free Survival

    Time frame: At 30 days and 1 year

    Disabling or non-disabling stroke

  4. Bleeding & Vascular Complications

    Time frame: 30 days

    Major and minor bleeding

Sponsors and collaborators

Lead sponsor

JenaValve Technology, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2022
Study completion
2027
First posted
Apr 11, 2016
Registry last updated
Nov 18, 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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