Clinical trial NCT02071849: HAART 200 Aortic Valve Annuloplasty Trial
Official title: HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aortic Insufficiency
Keywords: Aortic Insufficiency
Aortic Regurgitation
Lead sponsor: Biostable Science & Engineering
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 20
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: The HAART 200 "Aortic Annuloplasty during Bicuspid Aortic Valve Reconstruction" Trial is a prospective, non-randomized, multi-center trial to evaluate the safety and effectiveness of the HAART 200 bicuspid annuloplasty ring when used to surgically stabilize the aortic valve annulus in patients undergoing repair of bicuspid aortic valves (BAV) for predominant aortic insufficiency (AI).

Detailed description: Aortic valve disease is the most common valvular heart disease with approximately 200,000 patients per year undergoing conventional aortic valve replacement in North America and Europe. Around 60% of valves have Aortic Stenosis (AS) and 40% of have Aortic Insufficiency, which is the failure of the aortic valve to close completely during diastole, causing blood to flow from the aorta back into the left ventricle. Bicuspid valve morphology is present in a fourth to a third of patients coming to surgical intervention, and constitutes a very important subset. Several conditions are associated with bicuspid disease, including ascending aortic or root aneurysms in up to a third.

Traditional management of aortic valve and root disease has been with aortic valve replacement, with or without root replacement (Bentall Procedure). However, as has been observed in patients with mitral valve repair, the option of maintaining one's reconstructed native valve versus a replacement, either bioprosthetic or mechanical, can have multiple benefits. The advantages of repair include: the avoidance of prosthetic valve related complications and structural degeneration with bioprosthetic valves over 10-15 years and elimination of the need for anticoagulation and related problems with mechanical valves in younger patients. The significantly lower rate of endocarditis after repair is a major impetus to increasing performance of BAV reconstruction. Thus, aortic valve repair currently is established as an excellent option for patients with BAV. However, with connective tissue disorders being an inherent feature of BAV, outcomes have been less stable long-term than for trileaflet repair, primarily because of late annular redilatation in BAV disease.

Therefore, this study is designed to evaluate the safety and effectiveness of annular stabilization with a bicuspid annuloplasty ring in patients undergoing repair of a bicuspid aortic valve for predominant aortic insufficiency.

Eligibility criteria: Inclusion Criteria:

1. The subject is 18 years of age or older
2. The subject has bi-leaflet aortic valve morphology
3. The subject has documented aortic valve disease which may or may not include:

   * Aortic valve insufficiency
   * Ascending aortic or aortic root pathology
   * Other pathology of the ascending aorta that requires elective aortic replacement
   * Associated stable one or two vessel coronary disease requiring concomitant coronary bypass
   * Patients with recurrent severe AI (Grade 3 or 4) after prior bicuspid repair who are undergoing re-repair because of annular re-dilatation
   * All bicuspid annular and leaflet configurations will be included
4. The subject needs:

   * correction of BAV annular dilatation in patients with chronic AI and dilated annulus
   * restoration of a circular annular shape in patients with bicuspid valve and expansion of sinus to sinus dimensions
   * stabilization of annular geometry long-term in rare bicuspid valve patients with severe AI and minimal annular dilatation
5. The 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
6. The subject has reviewed and signed the written informed consent form
7. The subject agrees to return for all follow-up evaluations for the duration of the study (i.e. geographically stable)

Exclusion Criteria:

1. All patients will be excluded who require emergency surgery for any reason.
2. All the patients who have had a prior heart valve replacement
3. The subject's aortic valve morphology is not bicuspid.
4. The subject has active endocarditis
5. The subject has mixed stenosis and regurgitation of the aortic valve with predominant stenosis
6. Heavily calcified BAV valves, calcified aortic roots, or "porcelain aortas"
7. Leukopenia with a White Blood Cell (WBC) of less than 3000
8. Acute anemia with a Hgb less than 9mg%
9. Platelet count less than 100,000 cells/mm3
10. History of a defined bleeding diathesis or coagulopathy or the subject refuses blood transfusions
11. Active infection requiring antibiotic therapy (if temporary illness, subjects may enroll 2-4 weeks after discontinuation of antibiotics)
12. Subjects in whom transesophageal echocardiography (TEE) is contraindicated
13. Low Ejection Fraction (EF) \< 35%
14. Life expectancy \< 1 year, or severe comorbidities, such as dialysis or severe Chronic Obstructive Pulmonary Disease (COPD)
15. 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
16. The subject is a minor, an illicit drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent
17. The subject is pregnant or lactating
18. Recent (within 6 months) cerebrovascular accident (CVA) or a transient ischemic attack (TIA)
19. Myocardial Infarction (MI) within one month of trial inclusion
20. The subject has a known intolerance to titanium or polyester
21. The subject has documented unstable or \> 2 vessel coronary disease
22. 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 postprocedure
measure: Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
timeFrame: 6 months postprocedure
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 postprocedure
measure: Actuarial Freedom From Clinical Cardiovascular Events
timeFrame: 2 years postprocedure
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: Baseline and 2 years
measure: New York Heart Association (NYHA) Functional Capacity Classification
timeFrame: 6 months postprocedure
measure: NYHA Functional Capacity Classification
timeFrame: 2 years postprocedure
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: Left Ventricular (LV) Mass - Change From Baseline
timeFrame: Baseline and 6 months
measure: LV Mass - Change From Baseline
timeFrame: Baseline and 2 years
measure: Left Ventricular Internal Dimension (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: Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
timeFrame: Baseline and 6 months
measure: Left Ventricular Ejection Fraction (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: München
country: Germany
facility: München Heart Center
state: Bavaria
city: Köln
country: Germany
facility: Uniklinik Köln
state: North Rhine-Westphalia
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Herz- und Gefäßchirurgie
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Süd
Study officials:
affiliation: München Heart Center
name: Dominico Mazzitelli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10.