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HAART Model 300 Annuloplasty Ring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering
ClinicalTrials.gov Identifier:
NCT01400841
First received: July 21, 2011
Last updated: September 30, 2016
Last verified: September 2016
  Purpose
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

Condition Intervention
Aortic Regurgitation
Device: HAART 300 Annuloplasty Device

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 Intra-annular Mounting Frame

Further study details as provided by Biostable Science & Engineering:

Primary Outcome Measures:
  • Primary Safety Outcome Measure: Event-free Survival [ Time Frame: 1 month postprocedure ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    Event-free survival is defined as survival free from device-related death

  • Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    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 - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)


Secondary Outcome Measures:
  • Implant Procedure Success [ Time Frame: discharge or 14 days postprocedure, whichever comes first ] [ Designated as safety issue: Yes ]

    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) ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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: 6 months postprocedure ] [ Designated as safety issue: No ]
    Transthoracic echocardiography parameter

  • Peak Gradient - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Transthoracic echocardiography parameter

  • Mean Gradient - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Transthoracic echocardiography parameter

  • Mean Gradient - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Transthoracic echocardiography parameter

  • LV Mass - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular mass. Transthoracic echocardiography parameter.

  • LV Mass - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular mass. Transthoracic echocardiography parameter.

  • LVID Diastole - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  • LVID Diastole - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  • LVID Systole - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  • LVID Systole - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular internal dimension. Transthoracic echocardiography parameter.

  • LV Diastolic Volume - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

  • LV Diastolic Volume - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

  • LV Systolic Volume - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular systolic volume. Transthoracic echocardiography parameter.

  • LV Systolic Volume - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular systolic volume. Transthoracic echocardiography parameter.

  • LVEF - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

  • LVEF - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

  • Cardiac Output - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Stroke volume x heart rate. Transthoracic echocardiography parameter.

  • Cardiac Output - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Stroke volume x heart rate. Transthoracic echocardiography parameter.

  • Cardiac Index - Change From Baseline [ Time Frame: 6 months postprocedure ] [ Designated as safety issue: No ]
    Hemodynamic parameter computed as cardiac output divided by body surface area

  • Cardiac Index - Change From Baseline [ Time Frame: 2 years postprocedure (extended follow-up) ] [ Designated as safety issue: No ]
    Hemodynamic parameter computed as cardiac output divided by body surface area


Enrollment: 18
Study Start Date: January 2012
Study Completion Date: September 2014
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HAART 300 Annuloplasty Device
Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Device: HAART 300 Annuloplasty Device
Implantation of device for aortic valve repair

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is 50 years old or older
  • The subject has a tricuspid aortic valve morphology
  • Patients with documented severe aortic insufficiency with aortic annular dilation without severe concomitant aortic stenosis
  • Patients referred to center for documented moderate to severe Chronic aortic regurgitation (AR) associated with annular dilatation with or without cusp prolapse of one, two, or all three leaflets
  • Patients with or without Sinotubular Junction (STJ) dilatation or aortic root aneurysms
  • Patients who are free of coronary disease or those with evidence of minor stable (1-2 vessel) coronary disease
  • Subject is willing to comply with specified follow-up evaluations, including transesophageal echocardiography if there are inadequate images by transthoracic echocardiography (TTE) to assess the aortic valve
  • The subject has signed the written informed consent
  • The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable
  • The subject is New York Hospital Association (NYHA) class II or III

Exclusion Criteria:

  • The subject has preexisting valve prosthesis in the atrial, the mitral, pulmonary, and/or tricuspid position
  • The subject requires an additional valve replacement
  • The subject's aortic valve morphology is not tricuspid
  • The subject has active endocarditis
  • Heavily calcified valves
  • Valvular retraction with severely reduced mobility
  • The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
  • The subject requires a repair of the mitral or tricuspid valve with the use of an annuloplasty device
  • Leukopenia
  • Acute anemia (Hb < 9mg%)
  • Platelet count <100,000 cell/mm3
  • Need for emergency surgery for any reason
  • History of bleeding diathesis or coagulopathy or the subject refuses blood transfusions
  • Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 4 weeks after discontinuation of antibiotics)
  • Subjects in whom transesophageal echocardiography (TEE) is contraindicated
  • Non elective presentation
  • Low Ejection Fraction (EF) EF < 40%
  • Life expectancy < 1 year
  • Rheumatic disease
  • The subject has severe leaflet fenestration or leaflets damaged by endocarditis
  • 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
  • The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
  • The subject is pregnant or lactating
  • This patient will not agree to return to the implant center for the required number of follow-up visits or is geographically unavailable for follow-up
  • The subject has not signed and dated the study informed consent
  • Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA)
  • Myocardial infarction (MI) within one month of trial inclusion
  • Have a known intolerance to titanium or polyester
  • Sole therapy for correction for patients with aortic root aneurysm
  • Subjects requiring simultaneous cardiac procedures
  • The subject has asymptomatic AR and a left ventricular ejection fraction (LVEF) > 50%
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01400841

Locations
Belgium
University Hospital Gasthuisberg
Leuven, Belgium, B-3000
Czech Republic
Institut klinicke a experimantalni mediciny
Prague, Czech Republic, 1958/9
Germany
German Heart Institute
Berlin, Germany, 13353
German Heart Center Munich
Munich, Germany, 80636
Sponsors and Collaborators
Biostable Science & Engineering
Investigators
Principal Investigator: Christof Stamm, M.D. German Heart Institute Berlin
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT01400841     History of Changes
Other Study ID Numbers: BSE 300  TP-01-013  TP-01-023 
Study First Received: July 21, 2011
Results First Received: September 30, 2016
Last Updated: September 30, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Biostable Science & Engineering:
Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair

Additional relevant MeSH terms:
Aortic Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 09, 2016