HAART Model 300 Annuloplasty Ring

Aortic Regurgitation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400841
• Other study ID #: BSE 300
• Secondary ID: TP-01-013TP-01-0
• Status: Completed
• Phase: N/A
• First received: July 21, 2011
• Last updated: September 12, 2016
• Start date: January 2012
• Est. completion date: September 2014

Study information

• Verified date: September 2016
• Source: Biostable Science & Engineering
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 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 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 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 LVEF > 50%

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Regurgitation
• Aortic Valve Insufficiency

Intervention

Device:
• HAART 300 Annuloplasty Device
Implantation of device for aortic valve repair

Locations

Country	Name	City	State
Belgium	University Hospital Gasthuisberg	Leuven
Czech Republic	Institut klinicke a experimantalni mediciny	Prague
Germany	German Heart Institute	Berlin
Germany	German Heart Center Munich	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Biostable Science & Engineering

Countries where clinical trial is conducted

Belgium,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary safety outcome measure: Event-free survival	Event-free survival is defined as survival free from device-related death	1 month postprocedure and 2 years postprocedure (extended follow-up)	Yes
Primary	Primary efficacy outcome measure: Aortic valvular regurgitation	Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	6 months postprocedure and 2 years postprocedure (extended follow-up)	No
Secondary	Implant procedure success	Success is defined as the absence of specified adverse events	discharge or 14 days postprocedure, whichever comes first and 2 years postprocedure (extended follow-up)	Yes
Secondary	Actuarial freedom from clinical cardiovascular events	Freedom from specified device and cardiovascular events	1 month postprocedure and 2 years postprocedure (extended follow-up)	Yes
Secondary	Event-free survival	Event-free survival is defined as survival free from device-related death	6 months postprocedure	Yes
Secondary	Left ventricle dimensions, volume and mass	Measures assessed by transthoracic echocardiography	6 months postprocedure and 2 years postprocedure (extended follow-up)	No
Secondary	Peak and mean systolic gradient	Measures assessed by transthoracic echocardiography	6 months postprocedure and 2 years postprocedure (extended follow-up)	No
Secondary	New York Heart Association (NYHA) Functional Capacity Classification	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 postprocedure and 2 years postprocedure (extended follow-up)	No