Clinical trial NCT01400841: HAART Model 300 Annuloplasty Ring
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Regurgitation
Keywords: Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Repair
Lead sponsor: Biostable Science & Engineering
Sponsor class: INDUSTRY
First posted: 2011-07-22
Enrollment: 18
Sex: ALL
Minimum age (years): 50
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 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

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.

Eligibility criteria: 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%

Primary outcomes:
measure: Primary Safety Outcome Measure: Event-free Survival
timeFrame: 1 month postprocedure
measure: Primary Safety Outcome Measure: Event-free Survival
timeFrame: 2 years postprocedure (extended follow-up)
measure: Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure
timeFrame: 6 months postprocedure
measure: Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure
timeFrame: 2 years postprocedure (extended follow-up)
Secondary outcomes:
measure: Implant Procedure Success
timeFrame: discharge or 14 days postprocedure, whichever comes first
measure: Implant Procedure Success
timeFrame: 2 years postprocedure (extended follow-up)
measure: Actuarial Freedom From Clinical Cardiovascular Events
timeFrame: 1 month postprocedure
measure: Actuarial Freedom From Clinical Cardiovascular Events
timeFrame: 2 years postprocedure
measure: Event-free Survival
timeFrame: 6 months postprocedure
measure: New York Heart Association (NYHA) Functional Capacity Classification
timeFrame: 6 months postprocedure
measure: New York Heart Association (NYHA) Functional Capacity Classification
timeFrame: 2 years postprocedure (extended follow-up)
measure: Peak Gradient - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: Peak Gradient - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: Mean Gradient - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: Mean Gradient - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LV Mass - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LV Mass - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LVID Diastole - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LVID Diastole - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LVID Systole - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LVID Systole - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LV Diastolic Volume - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LV Diastolic Volume - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LV Systolic Volume - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LV Systolic Volume - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: LVEF - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: LVEF - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: Cardiac Output - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: Cardiac Output - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
measure: Cardiac Index - Change From Baseline
timeFrame: Baseline, 6 months postprocedure
measure: Cardiac Index - Change From Baseline
timeFrame: Baseline, 2 years postprocedure (extended follow-up)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg
city: Prague
country: Czech Republic
facility: Institut klinicke a experimantalni mediciny
city: Berlin
country: Germany
facility: German Heart Institute
city: Munich
country: Germany
facility: German Heart Center Munich
Study officials:
affiliation: German Heart Institute
name: Christof Stamm, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.