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HAART 200 Aortic Valve Annuloplasty Trial

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ClinicalTrials.gov Identifier: NCT02071849
Recruitment Status : Completed
First Posted : February 26, 2014
Results First Posted : March 20, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering

Brief Summary:
The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).

Condition or disease Intervention/treatment Phase
Aortic Insufficiency Device: HAART 200 Aortic Valve Annuloplasty Device Not Applicable

Detailed Description:

Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.

Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.

Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
Study Start Date : September 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : August 2016

Arm Intervention/treatment
Experimental: Aortic Valve Repair
Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction
Device: HAART 200 Aortic Valve Annuloplasty Device
Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .




Primary Outcome Measures :
  1. Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. [ Time Frame: 6 months postprocedure ]
  2. Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months [ Time Frame: 6 months postprocedure ]
    Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)


Secondary Outcome Measures :
  1. Implant Procedure Success [ Time Frame: discharge or 14 days postprocedure, whichever comes first ]
    Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - Mitral valve impingement due to implant - implant dehiscence/migration into aorta - implant dehiscence/migration into left ventricle - Hemodynamics requiring intervention - Other adverse event resulting in reoperation, explantation, or permanent disability.

  2. Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 6 months postprocedure ]
    Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months

  3. Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 2 years postprocedure ]
    Freedom from specified clinical cardiovascular events 6 months postprocedure: - Device-related mortality - Complete heart block - Structural device failure - Endocarditis - Periprosthetic leak or dehiscence - Thromboembolism - Bleeding Event - Native Valve Deterioration - Valve Thrombosis - Hemolysis - Reoperation and explant at 6 months

  4. Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure. [ Time Frame: 2 years ]
  5. Aortic Insufficiency (AI) at 2 Years [ Time Frame: Baseline and 2 years ]
    Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)

  6. New York Heart Association (NYHA) Functional Capacity Classification [ Time Frame: 6 months postprocedure ]
    Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort

  7. NYHA Functional Capacity Classification [ Time Frame: 2 years postprocedure ]
    Four classes describing the effect of cardiac disease on physical activity: Class I - disease does not limit activity; Class II - slight limitation; Class III - marked limitation; Class IV - inability to carry out any physical activity without discomfort

  8. Peak Gradient - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Transthoracic echocardiography parameter

  9. Peak Gradient - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Transthoracic echocardiography parameter

  10. Mean Gradient - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Transthoracic echocardiography parameter

  11. Mean Gradient - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Transthoracic echocardiography parameter

  12. Left Ventricular (LV) Mass - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular mass. Transthoracic echocardiography parameter.

  13. LV Mass - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular mass. Transthoracic echocardiography parameter.

  14. Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  15. LVID Diastole - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  16. LVID Systole - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  17. LVID Systole - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  18. LV Diastolic Volume - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

  19. LV Diastolic Volume - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

  20. LV Systolic Volume - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular systolic volume. Transthoracic echocardiography parameter.

  21. LV Systolic Volume - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular systolic volume. Transthoracic echocardiography parameter.

  22. Left Ventricular Ejection Fraction (LVEF) - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

  23. Left Ventricular Ejection Fraction (LVEF) - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

  24. Cardiac Output - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Stroke volume x heart rate. Transthoracic echocardiography parameter.

  25. Cardiac Output - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Stroke volume x heart rate. Transthoracic echocardiography parameter.

  26. Cardiac Index - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Hemodynamic parameter computed as cardiac output divided by body surface area

  27. Cardiac Index - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Hemodynamic parameter computed as cardiac output divided by body surface area



Information from the National Library of Medicine

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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 is 18 years of age or older
  2. The subject has bi-leaflet aortic valve morphology
  3. The subject has documented aortic valve disease which may or may not include:

    • Aortic valve insufficiency
    • Ascending aortic or aortic root pathology
    • Other pathology of the ascending aorta that requires elective aortic replacement
    • Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
    • Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
    • All bicuspid annular and leaflet configurations will be included
  4. The subject needs:

    • correction of BAV annular dilatation in patients with chronic AI and dilated annulus
    • restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
    • stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
  5. The is willing to comply with specified follow-up evaluations, including transesophageal echocardiography (TEE) if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
  6. The subject has reviewed and signed the written informed consent form
  7. The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)

Exclusion Criteria:

  1. All patients will be excluded who require emergency surgery for any reason.
  2. All the patients who have had a prior heart valve replacement
  3. The subject's aortic valve morphology is not bicuspid.
  4. The subject has active endocarditis
  5. The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
  6. Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
  7. Leukopenia with a White Blood Cell (WBC) of less than 3000
  8. Acute anemia with a Hgb less than 9mg%
  9. Platelet count less than 100,000 cells/mm3
  10. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
  11. Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
  12. Subjects in whom transesophageal echocardiography (TEE) is contraindicated
  13. Low Ejection Fraction (EF) < 35%
  14. Life expectancy < 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD)
  15. The subject is or will be participating in a concomitant research study of an investigational product or has participated in such a study within the 30 days prior to screening
  16. The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
  17. The subject is pregnant or lactating
  18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  19. Myocardial Infarction (MI) within one month of trial inclusion
  20. The subject has a known intolerance to titanium or polyester
  21. The subject has documented unstable or > 2 vessel coronary disease
  22. The subject requires additional valve replacement or valve repair

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): NCT02071849


Locations
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Germany
München Heart Center
München, Bavaria, Germany, 80636
Uniklinik Köln
Köln, North Rhine-Westphalia, Germany, 50937
Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, Germany, 20246
Klinikum Nürnberg Süd
Nürnberg, Germany, 90471
Sponsors and Collaborators
Biostable Science & Engineering
Investigators
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Principal Investigator: Dominico Mazzitelli, MD München Heart Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT02071849     History of Changes
Other Study ID Numbers: TP-01-025
First Posted: February 26, 2014    Key Record Dates
Results First Posted: March 20, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Biostable Science & Engineering:
Aortic Insufficiency
Aortic Regurgitation
Additional relevant MeSH terms:
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Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases