CoreValve® System Australia/New Zealand Clinical Study

October 28, 2019 updated by: Medtronic Cardiovascular
To evaluate the performance, efficacy and safety of the percutaneous implantation of the CoreValve® prosthetic aortic valve in patients with severe symptomatic native aortic valve stenosis that have an elevated surgical risk

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.

Detailed Description

Prospective, non-randomized, single-arm multi-center trial conducted under a common protocol at 10 centers in Australia and New Zealand.

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.
634

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

  • Australia
    • New South Wales
      • Darlinghurst, New South Wales, Australia
        • St. Vincents Sydney
    • Queensland
      • Chermside, Queensland, Australia
        • Prince Charles Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
    • Victoria
      • Clayton, Victoria, Australia
        • Monash Hospital
      • Fitzroy, Victoria, Australia
        • St. Vincent's Melbourne
      • Melbourne, Victoria, Australia
        • Alfred Hospital
      • Melbourne, Victoria, Australia, 3004
        • Epworth Hospital
    • Western Australia
      • Perth, Western Australia, Australia
        • Royal Perth Hospital
  • New Zealand
      • Auckland, New Zealand
        • Mercy Hospital
      • Hamilton, New Zealand
        • Waikato Hospital

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

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Documented severe aortic valve stenosis
  2. Access vessel diameter >6 mm as defined pre procedure via angiographic measure
  3. Aortic valve annulus diameter ≥ 20 mm and < 29 mm as defined pre procedure by echocardiographic measure
  4. Ascending aorta diameter ≤ 43 mm at the sino-tubular junction

  5. Native aortic valve disease, defined as valve stenosis with an aortic valve area<1cm2 (<0.6cm2 /m2) as defined pre procedure by echocardiographic measure

    AND (Assessment of Surgical Risk)

    Age ≥ 80 years

    AND/OR

    Surgical risk calculated with logistic EuroSCORE ≥ 20%,

    AND/OR

    Age ≥ 65 years with one or two (but not more than 2) of the following criteria:

    • Cirrhosis of the liver (Child class A or B)
    • Pulmonary insufficiency : VMS < 1 liter
    • Previous cardiac surgery (CABG, valvular surgery)
    • Porcelain aorta
    • Pulmonary hypertension > 60 mmHg and high probability of cardiac surgery for other than valve replacement
    • Recurrent pulmonary embolus
    • Right ventricular insufficiency
    • Thoracic burning sequelae contraindicating open chest surgery
    • History of mediastinum radiotherapy
    • Severe connective tissue disease resulting in a contraindication to surgery
    • Cachexia (clinical impression)
  6. Study subjects must be willing and able to attend all follow-up visits within specified visit windows, and agree to undergo all protocol evaluations at each visit

Exclusion Criteria:

  1. Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, nitinol, porcine products, or contrast media which cannot be adequately pre-medicated
  2. Any sepsis, including active endocarditis.
  3. Recent myocardial infarction (<30 days)
  4. Any left ventricular or atrial thrombus as determined pre procedure by echocardiography
  5. Uncontrolled atrial fibrillation
  6. Mitral or tricuspid valvular insufficiency (> grade II)
  7. Previous aortic valve replacement (mechanical valve or stented bioprosthetic valve)
  8. Evolutive or recent CVA (cerebrovascular accident), (<3 months)
  9. Femoral, iliac or aortic vascular condition (e.g. stenosis, tortuosity), that make impossible insertion and endovascular access to the aortic valve
  10. Symptomatic carotid or vertebral arteries narrowing (> 70%) disease
  11. Abdominal or thoracic aortic aneurysm
  12. Bleeding diathesis or coagulopathy, or patient will refuse blood transfusion
  13. Evolutive disease with life expectancy less than one year
  14. Creatinine clearance < 20 ml/min
  15. Active gastritis or known peptic ulcer disease
  16. Pregnancy

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: Medtronic CoreValve® System Implantation
Patients with symptomatic severe aortic stenosis who have an elevated surgical risk
Device: Medtronic CoreValve® System
The Medtronic CoreValve® System device is designed to replace the native aortic valve without the requirement for open heart surgery and without concomitant surgical removal of the failed native valve in patients with symptomatic severe aortic stenosis who have an elevated surgical risk

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
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Rate
Time Frame: 30 days
Defined as a composite of all cause death, myocardial infarction(MI) (Q-wave & non-Q-wave), stroke, and re-intervention (defined as any emergent cardiac surgery or percutaneous re-intervention catheter procedure that repairs, otherwise alters or adjusts or replaces a previously implanted valve)
30 days
Percentage of Participants With Overall Device Success
Time Frame: 24-48 hours after the procedure or before the discharge
  • Vascular access, delivery and deployment of the device, and retrieval of the delivery system
  • Correct position of the device in the proper anatomical location (placement in the annulus with no impedance on device function)
  • Intended performance of the prosthetic valve (aortic valve area > 1.2 cm2 (by echocardiography using the continuity equation) and mean aortic valve gradient < 20 mmHg, without moderate or severe prosthetic valve aortic regurgitation)
  • Only one valve implanted
  • No occurrence of in-hospital MACCE
24-48 hours after the procedure or before the discharge
Cardiac-related Death
Time Frame: 30 days
Defined as all death resulting from a cardiac cause or complications of a cardiac procedure and / or death of an unknown cause; this category includes valve-related deaths and non-valve-related cardiac deaths (e.g. congestive heart failure, acute myocardial infarction, documented fatal arrhythmias).
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
All-Cause Mortality
Time Frame: 30 days
is defined per Valve Academic Research Consortium-1 consensus document (VARC-1), including Cardiovascular and non-cardiovascular mortality.
30 days
Myocardial Infarction
Time Frame: 30 days
Included Q-wave and non-Q-wave.
30 days
Stroke
Time Frame: 30 days
Is a neurological deficit lasting more than 24 hours, or lasting 24 hours or less with a brain imaging study showing infarction.
30 days
Re-intervention
Time Frame: 30 days
Any emergent surgical or percutaneous interventional catheter procedure that repairs, otherwise alters or adjusts, or replaces a previously implanted valve.
30 days

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.
Medtronic Cardiovascular

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic Australasia

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.
  • Study Director: Eric Vang, Medtronic
  • Principal Investigator: Ian T Meredith, MD, Monash Heart Medical Center

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

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 1, 2008

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.
October 1, 2014

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.
September 1, 2016

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).
November 17, 2009

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.
November 17, 2009

First Posted (Estimate)

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.
November 18, 2009

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.
November 12, 2019

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.
October 28, 2019

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.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • CV-PAVR-R2007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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