HAART Model 300 Annuloplasty Ring

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

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

Study Overview

• Status: Completed
• Conditions: Aortic Regurgitation
• 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. Therefore, potentially aortic valve repair is a good option for patients with AR or AI.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, B-3000
    • University Hospital Gasthuisberg
• Czech Republic
  • Prague, Czech Republic, 1958/9
    • Institut klinicke a experimantalni mediciny
• Germany
  • Berlin, Germany, 13353
    • German Heart Institute
  • Munich, Germany, 80636
    • German Heart Center Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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%

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

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 device for aortic valve repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Outcome Measure: Event-free Survival	Event-free survival is defined as survival free from device-related death	1 month postprocedure
Primary Safety Outcome Measure: Event-free Survival	Event-free survival is defined as survival free from device-related death	2 years postprocedure (extended follow-up)
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure	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
Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure	Aortic valvular regurgitation assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)	2 years postprocedure (extended follow-up)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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; 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.	discharge or 14 days postprocedure, whichever comes first
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; 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.	2 years postprocedure (extended follow-up)
Actuarial Freedom From Clinical Cardiovascular Events	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	1 month postprocedure
Actuarial Freedom From Clinical Cardiovascular Events	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	2 years postprocedure
Event-free Survival	Event-free survival is defined as survival free from device-related death	6 months postprocedure
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	2 years postprocedure (extended follow-up)
Peak Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline, 6 months postprocedure
Peak Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline, 2 years postprocedure (extended follow-up)
Mean Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline, 6 months postprocedure
Mean Gradient - Change From Baseline	Transthoracic echocardiography parameter	Baseline, 2 years postprocedure (extended follow-up)
LV Mass - Change From Baseline	Left ventricular mass. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LV Mass - Change From Baseline	Left ventricular mass. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
LVID Diastole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LVID Diastole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
LVID Systole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LVID Systole - Change From Baseline	Left ventricular internal dimension. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
LV Diastolic Volume - Change From Baseline	Left ventricular diastolic volume. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LV Diastolic Volume - Change From Baseline	Left ventricular diastolic volume. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
LV Systolic Volume - Change From Baseline	Left ventricular systolic volume. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LV Systolic Volume - Change From Baseline	Left ventricular systolic volume. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
LVEF - Change From Baseline	Left ventricular ejection fraction. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
LVEF - Change From Baseline	Left ventricular ejection fraction. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
Cardiac Output - Change From Baseline	Stroke volume x heart rate. Transthoracic echocardiography parameter.	Baseline, 6 months postprocedure
Cardiac Output - Change From Baseline	Stroke volume x heart rate. Transthoracic echocardiography parameter.	Baseline, 2 years postprocedure (extended follow-up)
Cardiac Index - Change From Baseline	Hemodynamic parameter computed as cardiac output divided by body surface area	Baseline, 6 months postprocedure
Cardiac Index - Change From Baseline	Hemodynamic parameter computed as cardiac output divided by body surface area	Baseline, 2 years postprocedure (extended follow-up)

Collaborators and Investigators

• Sponsor: Biostable Science & Engineering
• Investigators: Principal Investigator: Christof Stamm, M.D., German Heart Institute

Publications and helpful links

General Publications

• Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer C, Crooke PS, Schreiber C, Lange R. Geometric ring annuloplasty as an adjunct to aortic valve repair: clinical investigation of the HAART 300 device. Eur J Cardiothorac Surg. 2016 Mar;49(3):987-93. doi: 10.1093/ejcts/ezv234. Epub 2015 Jul 8.
• Mazzitelli D, Stamm C, Rankin JS, Pfeiffer S, Fischlein T, Pirk J, Choi YH, Detter C, Kroll J, Beyersdorf F, Shrestha M, Schreiber C, Lange R. Leaflet reconstructive techniques for aortic valve repair. Ann Thorac Surg. 2014 Dec;98(6):2053-60. doi: 10.1016/j.athoracsur.2014.06.052. Epub 2014 Dec 1.
• Mazzitelli D, Stamm C, Rankin JS, Nobauer C, Pirk J, Meuris B, Crooke PS, Wagner A, Beavan LA, Griffin CD, Powers D, Nasseri B, Schreiber C, Hetzer R, Lange R. Hemodynamic outcomes of geometric ring annuloplasty for aortic valve repair: a 4-center pilot trial. J Thorac Cardiovasc Surg. 2014 Jul;148(1):168-75. doi: 10.1016/j.jtcvs.2013.08.031. Epub 2013 Oct 8.
• Mazzitelli D, Nobauer C, Rankin JS, Badiu CC, Dorfmeister M, Crooke PS, Wagner A, Schreiber C, Lange R. Early results of a novel technique for ring-reinforced aortic valve and root restoration. Eur J Cardiothorac Surg. 2014 Mar;45(3):426-30. doi: 10.1093/ejcts/ezt407. Epub 2013 Aug 19.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: July 21, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): January 13, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Aortic Valve Insufficiency
• Other Study ID Numbers: BSE 300; TP-01-013 (Other Identifier: Biostable Science & Engineering, Inc); TP-01-023 (Other Identifier: Biostable Science & Engineering, Inc)

Plan for Individual participant data (IPD)

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