The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

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.

Study Overview

• Status: Completed
• Conditions: Aortic Insufficiency
• Intervention / Treatment: Device: HAART 300 Annuloplasty Device

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.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic, 140 21
    • Institute of Clinical and Experimental Medicine
• Germany
  • Berlin, Germany, 80636
    • German Heart Center
  • Freiburg, Germany, 79106
    • Klinik für Herz und Gefässchirurgie
  • Hamburg, Germany, 20246
    • Klinik und Poliklinik für Herz- und Gefäßchirurgie
  • Hannover, Germany, 30625
    • Hannover Medical School (MHH)
  • Köln, Germany, 50937
    • Uniklinik Köln
  • Munchen, Germany
    • Munchen Heart Center
  • Nürnberg, Germany, 90471
    • Klinikum Nürnberg Süd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure		6 months
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months	Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline and 6 months
Peak Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline and 2 years
Mean Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline and 6 months
Mean Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline and 2 years
LV Mass - Change From Baseline	Left ventricular mass. Transthoracic echocardiography parameter.	Baseline and 2 years
LVID Diastole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline and 2 years
LVID Systole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline and 6 months
LVID Systole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline and 2 years
LV Diastolic Volume - Change From Baseline	Left ventricular diastolic volume. Transthoracic echocardiography parameter.	Baseline and 6 months
LV Diastolic Volume - Change From Baseline	Left ventricular diastolic volume. Transthoracic echocardiography parameter.	Baseline and 2 years
LV Systolic Volume - Change From Baseline	Left ventricular systolic volume. Transthoracic echocardiography parameter.	Baseline and 6 months
LV Systolic Volume - Change From Baseline	Left ventricular systolic volume. Transthoracic echocardiography parameter.	Baseline and 2 years
Cardiac Output - Change From Baseline	Stroke volume x heart rate. Transthoracic echocardiography parameter.	Baseline and 6 months
Cardiac Output - Change From Baseline	Stroke volume x heart rate. Transthoracic echocardiography parameter.	Baseline and 2 years
Cardiac Index - Change From Baseline	Hemodynamic parameter computed as cardiac output divided by body surface area	Baseline and 6 months
Cardiac Index - Change From Baseline	Hemodynamic parameter computed as cardiac output divided by body surface area	Baseline and 2 years
Implant Procedure Success	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.	discharge or 14 days postprocedure, whichever comes first
Actuarial Freedom From Clinical Cardiovascular Events	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	6 months
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure		2 years
Aortic Insufficiency (AI) at 2 Years	Assessed by transthoracic echocardiography (TTE) and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	2 years
New York Heart Association (NYHA) Functional Capacity Classification at 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	6 months
New York Heart Association (NYHA) Functional Capacity Classification at 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	2 years
LV Mass - Change From Baseline	Left ventricular mass. Transthoracic echocardiography parameter.	Baseline and 6 months
LVID Diastole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline and 6 months
LVEF - Change From Baseline	Left ventricular ejection fraction. Transthoracic echocardiography parameter.	Baseline and 6 months
LVEF - Change From Baseline	Left ventricular ejection fraction. Transthoracic echocardiography parameter.	Baseline and 2 years

Collaborators and Investigators

• Sponsor: Biostable Science & Engineering

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (ACTUAL): June 1, 2014
• Study Completion (ACTUAL): November 1, 2015

Study Registration Dates

• First Submitted: November 20, 2012
• First Submitted That Met QC Criteria: November 23, 2012
• First Posted (ESTIMATE): November 26, 2012

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Aortic Insufficiency (AI) Aortic Regurgitation (AR)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: TP-01-022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED