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Behavior of Valve Leaflets (BELIEVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03200574
Recruitment Status : Active, not recruiting
First Posted : June 27, 2017
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
LivaNova

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Aortic-valve Replacement Diagnostic Test: 4D Cardiac CT Scan Device: LivaNova Bioprothetic Aortic Valve Implant Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, multi-center trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical Aortic Valve Implant
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Aortic Valve
LivaNova bioprosthetic aortic heart valve replacement
Diagnostic Test: 4D Cardiac CT Scan
4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy

Device: LivaNova Bioprothetic Aortic Valve Implant
Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.




Primary Outcome Measures :
  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.


Secondary Outcome Measures :
  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.

  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.

  3. Reduction in leaflet motion by relationship to devices, procedure, or other causes [ 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

  4. Freedom from all-cause mortality [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  5. Freedom from valve re-intervention [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  6. Freedom from myocardial infarction [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  7. Freedom from structural valve deterioration [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  8. Freedom from moderate or severe valve regurgitation [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  9. Freedom from valve endocarditis [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  10. Freedom from valve thrombosis [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  11. Freedom from thromboembolic events [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  12. Freedom from hemolysis [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  13. Freedom from major bleeding [ Time Frame: up to 1 year post-implant ]
    Survival data will be evaluated using Kaplan-Meier method. The degree of uncertainty will be expressed with 90% confidence limits calculated per the method proposed by Greenwood

  14. New York Heart Association (NYHA) Assessment [ Time Frame: 1 year post-implant ]
    NYHA assessment at 1 year post-implant.

  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. Doppler Velocity Index 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. 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)

  19. 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)

  20. 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)

  21. 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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
  2. The subject has any medical condition requiring long term (> 6 months) anticoagulation or dual antiplatelet therapy
  3. The subject has any clinical condition precluding the use of CT imaging with contrast
  4. The subject had a stroke or myocardial infarction (STEMI and NSTEMI) within 30 days of the planned valve implant surgery
  5. The subject has active endocarditis, myocarditis, or sepsis
  6. The subject is in cardiogenic shock manifested by low cardiac output and needing hemodynamic support
  7. The subject is already included in another clinical trial that could confound the results of this clinical investigation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03200574


Locations
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United States, Indiana
St. Vincent Cardiovascular Research Institute
Indianapolis, Indiana, United States, 46290
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, Maryland
Washington Adventist Hospital
Takoma Park, Maryland, United States, 20912
United States, Michigan
Oakwood Hospital
Dearborn, Michigan, United States, 48124
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Missouri Baptist Hospital
Saint Louis, Missouri, United States, 63131
United States, Tennessee
Centennial
Nashville, Tennessee, United States, 37203
United States, Virginia
Valley Health
Winchester, Virginia, United States, 22601
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Montreal Heart Institute
Montréal, Quebec, Canada, H1T 1C8
Universite Laval
Québec, Quebec, Canada, G1V4G5
Sponsors and Collaborators
LivaNova
Investigators
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Principal Investigator: Niv Ad, MD Washington Adventist Hospital
Principal Investigator: Federico Asch, MD Medstar Health Research Institute
Publications:

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Responsible Party: LivaNova
ClinicalTrials.gov Identifier: NCT03200574    
Other Study ID Numbers: APR002
First Posted: June 27, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by LivaNova:
Perceval