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The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering
ClinicalTrials.gov Identifier:
NCT01732835
First received: November 20, 2012
Last updated: January 30, 2017
Last verified: January 2017
  Purpose
This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.

Condition Intervention
Aortic Insufficiency
Device: HAART 300 Annuloplasty Device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

Further study details as provided by Biostable Science & Engineering:

Primary Outcome Measures:
  • Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure [ Time Frame: 6 months ]
  • Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months [ Time Frame: 6 months ]
    Assessed by transthoracic echocardiography (TTE) 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 ]
    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 - 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: 6 months ]
    Freedom from specified clinical cardiovascular events at 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

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

  • New York Heart Association (NYHA) Functional Capacity Classification at 6 Months [ Time Frame: 6 months ]
    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 at 2 Years [ Time Frame: 2 years ]
    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 and 6 months ]
    Transthoracic echocardiography parameter

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

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

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

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

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

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

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

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

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

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

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

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

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

  • LVEF - Change From Baseline [ Time Frame: Baseline and 6 months ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

  • LVEF - Change From Baseline [ Time Frame: Baseline and 2 years ]
    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

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

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

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

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


Enrollment: 68
Study Start Date: December 2012
Study Completion Date: November 2015
Primary Completion Date: June 2014 (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 HAART 300 Annuloplasty 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.

  Eligibility

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

Inclusion Criteria:

  • Subject is 18 years of age or older
  • Subject has tri-leaflet aortic valve morphology
  • Subject has documented aortic valve disease which may or may not include:

    1. aortic valve insufficiency
    2. aortic root pathology
    3. pathology of the ascending aorta
    4. patients with associated stable one or two vessel coronary disease requiring concomitant coronary bypass
  • Subject 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
  • Subject has reviewed and signed the written informed consent form
  • Subject agrees to return for all follow-up evaluations for the duration of the study (i.e.,. geographically stable)

Exclusion Criteria:

  • The subject has pre-existing valve prosthesis in the aortic position
  • The subject's aortic valve morphology is not tri-leaflet
  • The subject has active endocarditis
  • Heavily calcified valves
  • The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
  • 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
  • Low Ejection Fraction (EF) EF < 35%
  • Life expectancy < 1 year
  • 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
  • Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
  • Myocardial Infarction (MI) within one month of trial inclusion
  • The subject has a known intolerance to titanium or polyester
  • The subject has documented unstable or > 2 vessel coronary disease
  • The subject requires additional valve replacement or valve repair
  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: NCT01732835

Locations
Czech Republic
Institute of Clinical and Experimental Medicine
Prague, Czech Republic, 140 21
Germany
German Heart Center
Berlin, Germany, 80636
Klinik für Herz und Gefässchirurgie
Freiburg, Germany, 79106
Klinik und Poliklinik für Herz- und Gefäßchirurgie
Hamburg, Germany, 20246
Hannover Medical School (MHH)
Hannover, Germany, 30625
Uniklinik Köln
Köln, Germany, 50937
Munchen Heart Center
Munchen, Germany
Klinikum Nürnberg Süd
Nürnberg, Germany, 90471
Sponsors and Collaborators
Biostable Science & Engineering
Investigators
Principal Investigator: Dominico Mazzitelli, MD Munchen Heart Center
  More Information

Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT01732835     History of Changes
Other Study ID Numbers: TP-01-022
Study First Received: November 20, 2012
Results First Received: October 6, 2016
Last Updated: January 30, 2017
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Biostable Science & Engineering:
Aortic Insufficiency (AI) Aortic Regurgitation (AR)

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

ClinicalTrials.gov processed this record on April 21, 2017