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Completed

NCT Number: NCT03200574

Behavior of Valve Leaflets Following Aortic Valve Implant

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant.

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Key information

Conditions

Aortic-valve Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Michael's Hospital, Toronto, Ontario, Canada

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About this study

This is a prospective, interventional, multi-center trial to report the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve up to 1 year post implant, on patients that are off anticoagulation for at least 30 days. A minimum of 75 subjects with evaluable 4D CT scans will be enrolled at approximately 11 investigational sites where the devices are commercially available. For asymptomatic subjects, PIs and subjects will be blinded from the CT imaging results and from the Core Lab findings.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The subject has been successfully implanted with a commercially approved LivaNova bioprosthetic valve according to the instructions for use (IFU)
  • The subject has signed the informed consent.
  • The subject is at least 18 years of age at the time of implant and consent signature
  • The subject will be available for post-operative follow-up through one year

Exclusion criteria

  • The subject has a planned concomitant cardiac procedure other than coronary artery bypass graft (CABG) and septal myectomy, including MAZE procedures, atrial fibrillation surgery, and left atrial appendage exclusion or resection, or has a prosthetic heart valve or annuloplasty ring in any position
  • The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy
  • The subject has any clinical condition precluding the use of CT imaging with contrast
  • The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
  • The subject has active endocarditis, myocarditis, or sepsis
  • The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
  • The subject is already included in another clinical trial that could confound the results of this clinical investigation

Treatment and study plan

4D Cardiac CT Scan

Diagnostic Test

4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy

LivaNova Bioprothetic Aortic Valve Implant

Device

Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.

Primary outcomes

  1. Reduction in Leaflet Motion

    Time frame: 1 year post-implant

    Report the overall incidence of reduced leaflet motion identified by CT imaging in commercially approved LivaNova bioprosthetic aortic heart valves up to 1 year post implant on patients that are off anticoagulation for at least 30 days.

    The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).

Secondary outcomes

  1. Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes

    Time frame: up to 1 year post-implant

    Incidence of reduced leaflet motion in symptomatic and asymptomatic subjects based on CT outcomes and anticoagulation and dual antiplatelet treatment modalities up to 1 year post-implant.

    The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).

  2. Reduced Leaflet Motion Through 4D Volume-rendered CT Scan

    Time frame: up to 1 year post-implant

    Incidence of reduced leaflet motion through 4D volume-rendered CT scan with contrast up to 1 year post-implant, in subjects in which reduced leaflet motion was previously detected.

    The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).

  3. Reduction in Leaflet Motion by Relationship to Devices or Procedure

    Time frame: up to 1 year post-implant

    Incidence of reduced leaflet motion considering relationship to the devices, procedure, or other causes up to 1 year post-implant The valve leaflets will be assessed using 4D-VR (volume-rendered) CT imaging. Leaflet motion in all leaflets will be defined as normal, mildly reduced (<50% reduction in leaflet opening), moderately reduced (50-70% reduction in leaflet motion), severely reduced (>70% reduction in leaflet motion) and immobile (no or negligible leaflet motion).

  4. Freedom From All-cause Mortality

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from all-cause mortality

  5. Freedom From Valve Re-intervention

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from valve reintervention

  6. Freedom From Myocardial Infarction

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from myocardial infarction

  7. Freedom From Structural Valve Deterioration

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from structural valve deterioration

  8. Freedom From Moderate or Severe Valve Regurgitation

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from moderate or severe valve regurgitation

  9. Freedom From Valve Endocarditis

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from valve endocarditis

  10. Freedom From Valve Thrombosis

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from valve thrombosis

  11. Freedom From Thromboembolic Events

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from thromboembolic events

  12. Freedom From Hemolysis

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from hemolysis

  13. Freedom From Major Bleeding

    Time frame: up to 1 year post-implant

    Number and incidence of subjects free from major bleeding

  14. New York Heart Association (NYHA) Assessment

    Time frame: 1 year post-implant

    Number and incidence of subjects in the different NYHA class at 1 year post-implant.

    NYHA I = Subjects with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or angina.

    NYHA II = Subjects with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or angina.

    NYHA III = Subjects with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or angina.

    NYHA IV = Subjects with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or angina may be present even at rest. If any physical activity is undertaken, discomfort is increased.

  15. Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

  16. Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

  17. Effective Orifice Area Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

  18. Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

  19. Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

  20. Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    Time frame: up to 1 year post-implant

    Summary statistics (means, Standard Deviation, median, quartiles and range values for continuous variables; count and frequency distributions for categorical variables) of Hemodynamic assessment up to 1 year post-implant through Echocardiographic Core Lab transthoracic echocardiogram (TTE)

Sponsors and collaborators

Lead sponsor

Corcym S.r.l

Industry

Collaborators

  • LivaNova

Registry information

Official study title

Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant

Acronym: BELIEVE

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Jun 27, 2017
Registry last updated
Mar 6, 2024

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.