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Aortic-valve ReplacementBELIEVENCT03200574

Behavior of Valve Leaflets Following Aortic Valve Implant

A study testing 4D Cardiac CT Scan and LivaNova Bioprothetic Aortic Valve Implant in people with Aortic-valve Replacement, run by Corcym S.r.l at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic-valve Replacement
What is being tested?
4D Cardiac CT Scan and LivaNova Bioprothetic Aortic Valve Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
11 sitesin 2 countries
Study dates
6 Dec 2017to 25 Feb 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States8 sites

  • Oakwood Hospital

    Dearborn, Michigan, 48124

  • St. Vincent Cardiovascular Research Institute

    Indianapolis, Indiana, 46290

  • Centennial

    Nashville, Tennessee, 37203

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Maine Medical Center

    Scarborough, Maine, 04074

  • Missouri Baptist Hospital

    St Louis, Missouri, 63131

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Valley Health

    Winchester, Virginia, 22601

Other trials in United States

Canada3 sites

  • Montreal Heart Institute

    Montreal, Quebec, H1T 1C8

  • Universite Laval

    Québec, Quebec, G1V4G5

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

About this study

Official title: Behavior of Valve Leaflets and the Incidence of Reduced Mobility Post-surgical 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.

Read the 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.

Being tested
4D Cardiac CT Scan, LivaNova Bioprothetic Aortic Valve Implant
Keywords
Perceval

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 4D Cardiac CT ScanDiagnostic test

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

  • LivaNova Bioprothetic Aortic Valve ImplantDevice

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

Study groups in NCT03200574
Study groupRoleWhat they receive
Aortic ValveOtherLivaNova bioprosthetic aortic heart valve replacement
Receives: Diagnostic Test: 4D Cardiac CT Scan; Device: LivaNova Bioprothetic Aortic Valve Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in Leaflet Motion

    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).

    Measured: 1 year post-implant

Secondary outcomes (20)

  1. Leaflet Motion in Symptomatic and Asymptomatic Subjects Outcomes

    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).

    Measured: up to 1 year post-implant

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

    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).

    Measured: up to 1 year post-implant

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

    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).

    Measured: up to 1 year post-implant

  4. Freedom From All-cause Mortality

    Number and incidence of subjects free from all-cause mortality

    Measured: up to 1 year post-implant

  5. Freedom From Valve Re-intervention

    Number and incidence of subjects free from valve reintervention

    Measured: up to 1 year post-implant

  6. Freedom From Myocardial Infarction

    Number and incidence of subjects free from myocardial infarction

    Measured: up to 1 year post-implant

  7. Freedom From Structural Valve Deterioration

    Number and incidence of subjects free from structural valve deterioration

    Measured: up to 1 year post-implant

  8. Freedom From Moderate or Severe Valve Regurgitation

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

    Measured: up to 1 year post-implant

  9. Freedom From Valve Endocarditis

    Number and incidence of subjects free from valve endocarditis

    Measured: up to 1 year post-implant

  10. Freedom From Valve Thrombosis

    Number and incidence of subjects free from valve thrombosis

    Measured: up to 1 year post-implant

  11. Freedom From Thromboembolic Events

    Number and incidence of subjects free from thromboembolic events

    Measured: up to 1 year post-implant

  12. Freedom From Hemolysis

    Number and incidence of subjects free from hemolysis

    Measured: up to 1 year post-implant

  13. Freedom From Major Bleeding

    Number and incidence of subjects free from major bleeding

    Measured: up to 1 year post-implant

  14. New York Heart Association (NYHA) Assessment

    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.

    Measured: 1 year post-implant

  15. Aortic Peak Gradient Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

  16. Aortic Mean Gradient Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

  17. Effective Orifice Area Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

  18. Global Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

  19. Central Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

  20. Paravalvular Aortic Regurgitation Through Transthoracic Echocardiogram (TTE)

    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)

    Measured: up to 1 year post-implant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2017
  2. Study start6 Dec 2017
  3. Primary completion15 Jun 2020
  4. Study completion25 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, multi-center trial
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03200574
Sponsor's protocol ID
APR002
Acronym
BELIEVE
Status last verified
Mar 2024
First submitted
9 Jun 2017
Last updated
6 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Adams DH, Popma JJ, Reardon MJ. Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014 Sep 4;371(10):967-8. doi: 10.1056/NEJMc1408396. No abstract available.

    PubMed 25184874

  • Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.

    PubMed 20961243

  • Mohr FW, Holzhey D, Mollmann H, Beckmann A, Veit C, Figulla HR, Cremer J, Kuck KH, Lange R, Zahn R, Sack S, Schuler G, Walther T, Beyersdorf F, Bohm M, Heusch G, Funkat AK, Meinertz T, Neumann T, Papoutsis K, Schneider S, Welz A, Hamm CW; GARY Executive Board. The German Aortic Valve Registry: 1-year results from 13,680 patients with aortic valve disease. Eur J Cardiothorac Surg. 2014 Nov;46(5):808-16. doi: 10.1093/ejcts/ezu290. Epub 2014 Jul 30.

    PubMed 25079769

  • Laschinger JC, Wu C, Ibrahim NG, Shuren JE. Reduced Leaflet Motion in Bioprosthetic Aortic Valves--The FDA Perspective. N Engl J Med. 2015 Nov 19;373(21):1996-8. doi: 10.1056/NEJMp1512264. Epub 2015 Oct 5. No abstract available.

    PubMed 26437127

  • Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.

    PubMed 26436963

  • Beholz S, Repossini A, Livi U, Schepens M, El Gabry M, Matschke K, Trivedi U, Eckel L, Dapunt O, Zamorano JL. The Freedom SOLO valve for aortic valve replacement: clinical and hemodynamic results from a prospective multicenter trial. J Heart Valve Dis. 2010 Jan;19(1):115-23.

    PubMed 20329497

  • Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.

    PubMed 26443880

  • Grubitzsch H, Wang S, Matschke K, Glauber M, Heimansohn D, Tan E, Francois K, Thalmann M. Clinical and haemodynamic outcomes in 804 patients receiving the Freedom SOLO stentless aortic valve: results from an international prospective multicentre study. Eur J Cardiothorac Surg. 2015 Mar;47(3):e97-104. doi: 10.1093/ejcts/ezu471. Epub 2014 Dec 13.

    PubMed 25501554

  • Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Guyton RA, O'Gara PT, Ruiz CE, Skubas NJ, Sorajja P, Sundt TM 3rd, Thomas JD; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2014 AHA/ACC guideline for the management of patients with valvular heart disease: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol. 2014 Jun 10;63(22):e57-185. doi: 10.1016/j.jacc.2014.02.536. Epub 2014 Mar 3. No abstract available.

    PubMed 24603191

  • Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.

    PubMed 21639811

Questions about this trial

What is this clinical trial studying?

A study testing 4D Cardiac CT Scan and LivaNova Bioprothetic Aortic Valve Implant in people with Aortic-valve Replacement, run by Corcym S.r.l at 11 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Leaflet Motion (time frame: 1 year post-implant). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03200574, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.

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