Clinical trial NCT01732835: The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance
Official title: The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Insufficiency
Keywords: Aortic Insufficiency (AI) Aortic Regurgitation (AR)
Lead sponsor: Biostable Science & Engineering
Sponsor class: INDUSTRY
First posted: 2012-11-26
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure
timeFrame: 6 months
measure: Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
timeFrame: 6 months
Secondary outcomes:
measure: Implant Procedure Success
timeFrame: discharge or 14 days postprocedure, whichever comes first
measure: Actuarial Freedom From Clinical Cardiovascular Events
timeFrame: 6 months
measure: Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure
timeFrame: 2 years
measure: Aortic Insufficiency (AI) at 2 Years
timeFrame: 2 years
measure: New York Heart Association (NYHA) Functional Capacity Classification at 6 Months
timeFrame: 6 months
measure: New York Heart Association (NYHA) Functional Capacity Classification at 2 Years
timeFrame: 2 years
measure: Peak Gradient - Change From Baseline
timeFrame: Baseline and 6 months
measure: Peak Gradient - Change From Baseline
timeFrame: Baseline and 2 years
measure: Mean Gradient - Change From Baseline
timeFrame: Baseline and 6 months
measure: Mean Gradient - Change From Baseline
timeFrame: Baseline and 2 years
measure: LV Mass - Change From Baseline
timeFrame: Baseline and 6 months
measure: LV Mass - Change From Baseline
timeFrame: Baseline and 2 years
measure: LVID Diastole - Change From Baseline
timeFrame: Baseline and 6 months
measure: LVID Diastole - Change From Baseline
timeFrame: Baseline and 2 years
measure: LVID Systole - Change From Baseline
timeFrame: Baseline and 6 months
measure: LVID Systole - Change From Baseline
timeFrame: Baseline and 2 years
measure: LV Diastolic Volume - Change From Baseline
timeFrame: Baseline and 6 months
measure: LV Diastolic Volume - Change From Baseline
timeFrame: Baseline and 2 years
measure: LV Systolic Volume - Change From Baseline
timeFrame: Baseline and 6 months
measure: LV Systolic Volume - Change From Baseline
timeFrame: Baseline and 2 years
measure: LVEF - Change From Baseline
timeFrame: Baseline and 6 months
measure: LVEF - Change From Baseline
timeFrame: Baseline and 2 years
measure: Cardiac Output - Change From Baseline
timeFrame: Baseline and 6 months
measure: Cardiac Output - Change From Baseline
timeFrame: Baseline and 2 years
measure: Cardiac Index - Change From Baseline
timeFrame: Baseline and 6 months
measure: Cardiac Index - Change From Baseline
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Institute of Clinical and Experimental Medicine
city: Berlin
country: Germany
facility: German Heart Center
city: Freiburg
country: Germany
facility: Klinik für Herz und Gefässchirurgie
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Herz- und Gefäßchirurgie
city: Hannover
country: Germany
facility: Hannover Medical School (MHH)
city: Köln
country: Germany
facility: Uniklinik Köln
city: Munchen
country: Germany
facility: Munchen Heart Center
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
Study officials:
affiliation: Munchen Heart Center
name: Dominico Mazzitelli, MD
role: PRINCIPAL_INVESTIGATOR
References: