Clinical Trial: HAART Model 300 Annuloplasty Ring

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Prospective, Non-randomized, Multi-center Trial to Evaluate the Safety and Effectiveness of the HAART Model 300 Annuloplasty Ring When Used to Surgically Repair a Leaking Aortic Valve Using a 3-D In

Brief Summary: This investigation is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART model 300 annuloplasty ring when used to surgically repair a leaking aortic valve using a 3-D intra-annular mounting frame

Detailed Summary:

Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations.

Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.


Sponsor: Biostable Science & Engineering

Current Primary Outcome:

  • Primary Safety Outcome Measure: Event-free Survival [ Time Frame: 1 month postprocedure ]
    Event-free survival is defined as survival free from device-related death
  • Primary Safety Outcome Measure: Event-free Survival [ Time Frame: 2 years postprocedure (extended follow-up) ]
    Event-free survival is defined as survival free from device-related death
  • Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure [ Time Frame: 6 months postprocedure ]
    Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
  • Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure [ Time Frame: 2 years postprocedure (extended follow-up) ]
    Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)


Original Primary Outcome: Event -free survival defined as survival free from device related death at 6 months post-procedure. [ Time Frame: 6 months ]

Current Secondary Outcome:

  • 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 or 14 days after the procedure:

    • Aortic annular dissection, rupture, or leaflet damage
    • Paravalvular leak > +2 or requiring intervention
    • 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.
  • Implant Procedure Success [ Time Frame: 2 years postprocedure (extended follow-up) ]

    Success is defined as the absence of specified adverse events evaluated through discharge or 14 days after the procedure:

    • Aortic annular dissection, rupture, or leaflet damage
    • Paravalvular leak > +2 or requiring intervention
    • 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.
  • Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 1 month postprocedure ]

    Freedom from specified clinical cardiovascular events 1 month 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 1 month
  • Actuarial Freedom From Clinical Cardiovascular Events [ Time Frame: 2 years postprocedure ]

    Freedom from specified clinical cardiovascular events 2 years 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 2 years
  • Event-free Survival [ Time Frame: 6 months postprocedure ]
    Event-free survival is defined as survival free from device-related death
  • 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
  • New York Heart Association (NYHA) Functional Capacity Classification [ Time Frame: 2 years postprocedure (extended follow-up) ]
    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
  • Peak Gradient - Change From Baseline [ Time Frame: Baseline, 6 months postprocedure ]
    Transthoracic echocardiography parameter
  • Peak Gradient - Change From Baseline [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]
    Transthoracic echocardiography parameter
  • Mean Gradient - Change From Baseline [ Time Frame: Baseline, 6 months postprocedure ]
    Transthoracic echocardiography parameter

    • Original Secondary Outcome:

    Information By: Biostable Science & Engineering

    Dates:
    Date Received: July 21, 2011
    Date Started: January 2012
    Date Completion:
    Last Updated: November 27, 2016
    Last Verified: November 2016