NVT ALLEGRA TAVI System TF in Failing Surgical Aortic Bioprosthesis (VIVALL)

January 7, 2020 updated by: NVT GmbH

Investigation of the Safety and Performance of the NVT ALLEGRA TAVI System TF in Patients With Failed Surgical Aortic Bioprosthesis and Elevated Surgical Risk

The study investigates the technical feasibility of the replacement of failed surgical bioprosthetic aortic valves by the ALLEGRA Transcatheter Heart Valve (THV) and describes the safety and performance profile

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Segeberg, Germany
        • Segeberger Kliniken, Herzzentrum
      • Bernau bei Berlin, Germany
        • Immanuel Klinik Bernau Herzzentrum Brandenburg
      • Halle (Saale), Germany
        • Mitteldeutsches Herzzentrum Universitätsklinikum Halle (Saale)
      • Hamburg, Germany
        • Asklepios Klinik St. Georg
      • Hamburg, Germany
        • Universitäres Herzzentrum Hamburg GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥18 years
  • Symptomatic degeneration of aortic bioprosthesis showing echocardiographically mean aortic gradient >40mmHg or peak jet velocity >4.0m/s and AVA<1.0cm2 OR symptomatic patients with severe bioprosthetic valve insufficiency.
  • High risk for redo surgery defined by STS ≥10% / EuroScore II ≥7% OR as assessed by the heart team
  • Has signed the Patient Informed Consent Form
  • Willing and able to comply with requirements of the study, including all follow-up visits
  • Female patients of childbearing potential have a negative pregnancy test ≤7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation

Exclusion Criteria:

  • Low position of the coronary ostia, especially in combination with shallow sinuses
  • Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  • Significant aortic disease such as severe obstructive calcification or marked tortuosity or kinking which will preclude a safe advancement of the ALLEGRA TAVI System TF
  • Iliofemoral vessel conditions such as severe obstructive calcification, severe tortuosity or kinking that would preclude safe placement of an 18 Fr introducer sheath or make endovascular access to the aortic valve impossible
  • Severe mitral insufficiency
  • Internal diameter of the bioprosthesis is ≤16 mm or >28 mm
  • Patient prosthesis mismatch (EOAi ≤0.65 cm2/m2) as the underlying cause of the poor valve function and need for re-intervention
  • Non-valvular stenosis as the underlying cause of the poor valve function and need for re-intervention
  • Failing pre-existing prosthetic heart valve or prosthetic ring in any other position than aortic
  • Partially detached leaflets that in the aortic position may obstruct a coronary ostium.
  • Existence of aortic conduit, aortic arch replacement, stentless bioprosthesis and autologous valve replacement
  • Paravalvular leak of the failing surgical bioprosthesis (between failing surgical bioprosthesis and native annulus)
  • LVEF <20%
  • Evidence of active endocarditis or other acute infections
  • End stage renal disease requiring chronic dialysis or creatinine clearance <20 ml/min or serum creatinine >3.0 mg/dl (264 µmol/l)
  • Known hypersensitivity to contrast media, which cannot be adequately pre-medicated or contraindication to anticoagulant or anti-platelet medication or to Nitinol alloy or to bovine tissue
  • Evidence of an acute myocardial infarction within the past 30 days
  • Cerebral vascular accident (TIA, Stroke) within past 6 months (≤180 days)
  • Evidence of active peptic ulcer or upper gastrointestinal bleeding within past 90 days
  • Untreated clinically significant coronary artery disease requiring revascularization
  • Hemodynamic instability (e.g. cardiogenic shock) requiring inotropic support or mechanical heart assistance (e.g. VAD, IABP)
  • Uncontrolled (therapy resistant) atrial fibrillation
  • Need for emergency surgery for any reason
  • Life expectancy ≤ 12 months due to other medical illness
  • Currently participating in another investigational drug or device study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Transcatheter Aortic Valve Implantation (TAVI) in failing surgical bioprosthesis
Device: Transcatheter Aortic Valve Implantation (TAVI)
Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean pressure gradient
Time Frame: immediately after index-procedure
immediately after index-procedure
30-days survival
Time Frame: 30 days
Proportion of participants with overall survival at 30 days
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cardiovascular mortality
Time Frame: 30 days
30 days
Hemodynamic parameters
Time Frame: up to12 months
pressure gradient, effective orifice area, velocity
up to12 months
Technical success of implantation
Time Frame: immediately after index-procedure
defined as absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND no severe (<0.65 cm2/m2) prosthesis - patient mismatch AND mean aortic valve gradient <20 mmHg AND no moderate or severe prosthetic valve regurgitation
immediately after index-procedure
Early safety
Time Frame: 30 days
all-cause mortality, all stroke (disabling and non-disabling), life-threatening bleeding, acute kidney injury stage 2 or 3 (including renal replacement therapy), coronary artery obstruction requiring Intervention, major vascular complication, valve-related dysfunction requiring repeat procedure
30 days
Time related valve safety
Time Frame: up to 12 months

structural valve deterioration as defined by

  • requiring repeat procedure (transcatheter or surgical heart valve replacement)

  • valve-related dysfunction defined by

    • mean aortic valve gradient ≥20 mmHg AND
    • no moderate or severe prosthetic valve regurgitation
up to 12 months
New Pacemaker implantation
Time Frame: up to 12 months
Proportion of patients with pacemaker implantations after index-procedure
up to 12 months
NYHA classification
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NVT GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ulrich Schaefer, MD, Universitäres Herzzentrum Hamburg, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 27, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 10, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NVT03VIV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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