HAART 200 Aortic Valve Annuloplasty Trial

• Sponsor: Biostable Science & Engineering (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02071849
• Collaborator: (none)
• Enrollment: 20
• Locations: 4
• Arm: 1
• Duration (Months): 35
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Aortic Insufficiency	Device: HAART 200 Aortic Valve Annuloplasty Device	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: HAART 200 Aortic Valve Annuloplasty During Bicuspid Aortic Valve Reconstruction Trial
• Study Start Date: Sep 1, 2013
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aortic Valve Repair Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction	Device: HAART 200 Aortic Valve Annuloplasty Device; Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .

Outcome Measures

Primary Outcome Measures

1. Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure. [6 months postprocedure]

2. Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months [6 months postprocedure]

   Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)

Secondary Outcome Measures

1. Implant Procedure Success [discharge or 14 days postprocedure, whichever comes first]

   Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - 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. Actuarial Freedom From Clinical Cardiovascular Events [6 months postprocedure]

   Freedom from specified clinical cardiovascular events 6 months 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 6 months

3. Actuarial Freedom From Clinical Cardiovascular Events [2 years postprocedure]

   Freedom from specified clinical cardiovascular events 6 months 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 6 months

4. Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure. [2 years]

5. Aortic Insufficiency (AI) at 2 Years [Baseline and 2 years]

   Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)

6. New York Heart Association (NYHA) Functional Capacity Classification [6 months postprocedure]

   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

7. NYHA Functional Capacity Classification [2 years postprocedure]

   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

8. Peak Gradient - Change From Baseline [Baseline and 6 months]

   Transthoracic echocardiography parameter

9. Peak Gradient - Change From Baseline [Baseline and 2 years]

   Transthoracic echocardiography parameter

10. Mean Gradient - Change From Baseline [Baseline and 6 months]

    Transthoracic echocardiography parameter

11. Mean Gradient - Change From Baseline [Baseline and 2 years]

    Transthoracic echocardiography parameter

12. Left Ventricular (LV) Mass - Change From Baseline [Baseline and 6 months]

    Left ventricular mass. Transthoracic echocardiography parameter.

13. LV Mass - Change From Baseline [Baseline and 2 years]

    Left ventricular mass. Transthoracic echocardiography parameter.

14. Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline [Baseline and 6 months]

    Left ventricular internal dimension. Transthoracic echocardiography parameter.

15. LVID Diastole - Change From Baseline [Baseline and 2 years]

    Left ventricular internal dimension. Transthoracic echocardiography parameter.

16. LVID Systole - Change From Baseline [Baseline and 6 months]

    Left ventricular internal dimension. Transthoracic echocardiography parameter.

17. LVID Systole - Change From Baseline [Baseline and 2 years]

    Left ventricular internal dimension. Transthoracic echocardiography parameter.

18. LV Diastolic Volume - Change From Baseline [Baseline and 6 months]

    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

19. LV Diastolic Volume - Change From Baseline [Baseline and 2 years]

    Left ventricular diastolic volume. Transthoracic echocardiography parameter.

20. LV Systolic Volume - Change From Baseline [Baseline and 6 months]

    Left ventricular systolic volume. Transthoracic echocardiography parameter.

21. LV Systolic Volume - Change From Baseline [Baseline and 2 years]

    Left ventricular systolic volume. Transthoracic echocardiography parameter.

22. Left Ventricular Ejection Fraction (LVEF) - Change From Baseline [Baseline and 6 months]

    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

23. Left Ventricular Ejection Fraction (LVEF) - Change From Baseline [Baseline and 2 years]

    Left ventricular ejection fraction. Transthoracic echocardiography parameter.

24. Cardiac Output - Change From Baseline [Baseline and 6 months]

    Stroke volume x heart rate. Transthoracic echocardiography parameter.

25. Cardiac Output - Change From Baseline [Baseline and 2 years]

    Stroke volume x heart rate. Transthoracic echocardiography parameter.

26. Cardiac Index - Change From Baseline [Baseline and 6 months]

    Hemodynamic parameter computed as cardiac output divided by body surface area

27. Cardiac Index - Change From Baseline [Baseline and 2 years]

    Hemodynamic parameter computed as cardiac output divided by body surface area

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. 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

1. 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

2. The subject has reviewed and signed the written informed consent form

3. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	München Heart Center	München	Bavaria	Germany	80636
2	Uniklinik Köln	Köln	North Rhine-Westphalia	Germany	50937
3	Klinik und Poliklinik für Herz- und Gefäßchirurgie	Hamburg		Germany	20246
4	Klinikum Nürnberg Süd	Nürnberg		Germany	90471

Sponsors and Collaborators

• Biostable Science & Engineering

Investigators

• Principal Investigator: Dominico Mazzitelli, MD, München Heart Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Biostable Science & Engineering
• ClinicalTrials.gov Identifier: NCT02071849
• Other Study ID Numbers: TP-01-025
• First Posted: Feb 26, 2014
• Last Update Posted: Apr 17, 2017
• Last Verified: Mar 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Biostable Science & Engineering: Aortic Insufficiency; Aortic Regurgitation
• Additional relevant MeSH terms: Aortic Valve Insufficiency

Study Results

Participant Flow

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Period Title: 6-month Primary Endpoint
STARTED	20
COMPLETED	15
NOT COMPLETED	5
Period Title: 6-month Primary Endpoint
STARTED	15
COMPLETED	14
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Overall Participants	16
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.4 (11.3)
Age, Customized (Count of Participants)
18-29	3 18.8%
30-39	2 12.5%
40-49	6 37.5%
50-59	4 25%
60-69	1 6.3%
Sex: Female, Male (Count of Participants)
Female	2 12.5%
Male	14 87.5%
Region of Enrollment (participants) [Number]
Germany	16 100%
Aortic Insufficiency (Count of Participants)
0	1 6.3%
1+	3 18.8%
2+	2 12.5%
3+	5 31.3%
4+	3 18.8%
Grade not available	2 12.5%
New York Heart Association (NYHA) Functional Capacity (Count of Participants)
I	3 18.8%
II	13 81.3%
III	0 0%
IV	0 0%
Peak gradient (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	25.5 (22.3)
Mean gradient (mm Hg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mm Hg]	13.4 (12.9)
Left ventricular (LV) mass (g) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [g]	288.62 (90.23)
Left ventricular internal dimension (LVID) diastole (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	5.408 (0.952)
LVID systole (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	3.527 (0.793)
LV diastolic volume (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	144.5 (57.6)
LV systolic volume (ml) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ml]	69.1 (36.6)
Left ventricular ejection fraction (LVEF) (percentage of blood volume) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of blood volume]	53.86 (8.76)
Cardiac output (l/min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [l/min]	7.926 (2.365)
Cardiac index (l/min/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [l/min/m^2]	3.88 (1.16)

Outcome Measures

1. Primary Outcome

Title	Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure.
Time Frame	6 months postprocedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	16
Number (95% Confidence Interval) [percentage of participants]	100 625%

2. Primary Outcome

Title	Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months
Description	Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderately Severe (3+), or Severe (4+)
Time Frame	6 months postprocedure

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	15
0	5 31.3%
1+	6 37.5%
2+	4 25%
3+	0 0%
4+	0 0%

3. Secondary Outcome

Title	Implant Procedure Success
Description	Success is defined as the absence of specified adverse events evaluated through discharge following the procedure: - Aortic annular dissection, rupture, or leaflet damage - 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.
Time Frame	discharge or 14 days postprocedure, whichever comes first

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	16
Number (95% Confidence Interval) [percentage of participants]	100 625%

4. Secondary Outcome

Title	Actuarial Freedom From Clinical Cardiovascular Events
Description	Freedom from specified clinical cardiovascular events 6 months 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 6 months
Time Frame	6 months postprocedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	16
Number (95% Confidence Interval) [percentage of participants]	87.5 546.9%

5. Secondary Outcome

Title	Actuarial Freedom From Clinical Cardiovascular Events
Description	Freedom from specified clinical cardiovascular events 6 months 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 6 months
Time Frame	2 years postprocedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	16
Number (95% Confidence Interval) [percentage of participants]	81.2 507.5%

6. Secondary Outcome

Title	Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	16
Number (95% Confidence Interval) [percentage of participants]	100 625%

7. Secondary Outcome

Title	Aortic Insufficiency (AI) at 2 Years
Description	Aortic insufficiency assessed by transthoracic echocardiography and graded as None/Trace (0), Mild (1+), Moderate (2+), Moderate-to-Severe (3+), or Severe (4+)
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	14
0	2 12.5%
1+	11 68.8%
2+	1 6.3%
3+	0 0%
4+	0 0%

8. Secondary Outcome

Title	New York Heart Association (NYHA) Functional Capacity Classification
Description	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
Time Frame	6 months postprocedure

Outcome Measure Data

Analysis Population Description

Participants with an evaluation of this measure.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	15
I	15 93.8%
II	0 0%
III	0 0%
IV	0 0%

9. Secondary Outcome

Title	NYHA Functional Capacity Classification
Description	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
Time Frame	2 years postprocedure

Outcome Measure Data

Analysis Population Description

Participants with an evaluation of this measure.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	14
I	14 87.5%
II	0 0%
III	0 0%
IV	0 0%

10. Secondary Outcome

Title	Peak Gradient - Change From Baseline
Description	Transthoracic echocardiography parameter
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	1.1 (22.4)

11. Secondary Outcome

Title	Peak Gradient - Change From Baseline
Description	Transthoracic echocardiography parameter
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	1.4 (16.3)

12. Secondary Outcome

Title	Mean Gradient - Change From Baseline
Description	Transthoracic echocardiography parameter
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	12
Mean (Standard Deviation) [mm Hg]	1.2 (13.3)

13. Secondary Outcome

Title	Mean Gradient - Change From Baseline
Description	Transthoracic echocardiography parameter
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	11
Mean (Standard Deviation) [mm Hg]	2.4 (8.8)

14. Secondary Outcome

Title	Left Ventricular (LV) Mass - Change From Baseline
Description	Left ventricular mass. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	10
Mean (Standard Deviation) [g]	-53.98 (76.21)

15. Secondary Outcome

Title	LV Mass - Change From Baseline
Description	Left ventricular mass. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	10
Mean (Standard Deviation) [g]	-78.84 (88.00)

16. Secondary Outcome

Title	Left Ventricular Internal Dimension (LVID) Diastole - Change From Baseline
Description	Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	10
Mean (Standard Deviation) [cm]	-0.306 (0.843)

17. Secondary Outcome

Title	LVID Diastole - Change From Baseline
Description	Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	10
Mean (Standard Deviation) [cm]	-0.455 (1.023)

18. Secondary Outcome

Title	LVID Systole - Change From Baseline
Description	Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	8
Mean (Standard Error) [cm]	0.030 (0.531)

19. Secondary Outcome

Title	LVID Systole - Change From Baseline
Description	Left ventricular internal dimension. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	4
Mean (Standard Deviation) [cm]	-0.700 (1.108)

20. Secondary Outcome

Title	LV Diastolic Volume - Change From Baseline
Description	Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	6
Mean (Standard Deviation) [ml]	2.8 (41.3)

21. Secondary Outcome

Title	LV Diastolic Volume - Change From Baseline
Description	Left ventricular diastolic volume. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	7
Mean (Standard Deviation) [ml]	26.9 (40.9)

22. Secondary Outcome

Title	LV Systolic Volume - Change From Baseline
Description	Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	6
Mean (Standard Deviation) [ml]	1.3 (25.8)

23. Secondary Outcome

Title	LV Systolic Volume - Change From Baseline
Description	Left ventricular systolic volume. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	7
Mean (Standard Deviation) [ml]	7.9 (24.9)

24. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Description	Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	6
Mean (Standard Deviation) [percentage of blood volume]	0.00 (8.83)

25. Secondary Outcome

Title	Left Ventricular Ejection Fraction (LVEF) - Change From Baseline
Description	Left ventricular ejection fraction. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	7
Mean (Standard Deviation) [percentage of blood volume]	4.21 (10.02)

26. Secondary Outcome

Title	Cardiac Output - Change From Baseline
Description	Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	9
Mean (Standard Deviation) [l/min]	-0.932 (2.979)

27. Secondary Outcome

Title	Cardiac Output - Change From Baseline
Description	Stroke volume x heart rate. Transthoracic echocardiography parameter.
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	8
Mean (Standard Deviation) [l/min]	-2.145 (2.679)

28. Secondary Outcome

Title	Cardiac Index - Change From Baseline
Description	Hemodynamic parameter computed as cardiac output divided by body surface area
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 6 months.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	9
Mean (Standard Deviation) [l/min/m^2]	-0.50 (1.50)

29. Secondary Outcome

Title	Cardiac Index - Change From Baseline
Description	Hemodynamic parameter computed as cardiac output divided by body surface area
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

Participants with an echocardiogram evaluable for this measure at baseline and at 2 years.

Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
Measure Participants	8
Mean (Standard Deviation) [l/min/m^2]	-1.09 (1.28)

Adverse Events

Time Frame	2 years
Arm/Group Title	Aortic Valve Repair
Arm/Group Description	Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
All Cause Mortality
	Aortic Valve Repair
	Affected / at Risk (%)	# Events
Total	0/16 (0%)
Serious Adverse Events
	Aortic Valve Repair
	Affected / at Risk (%)	# Events
Total	8/16 (50%)
Cardiac disorders
Aortic vlave incompetence	3/16 (18.8%)	3
Arrhythmia	1/16 (6.3%)	1
Pericarditis	1/16 (6.3%)	1
Infections and infestations
Pneumonia	1/16 (6.3%)	1
Wound infection	1/16 (6.3%)	1
Injury, poisoning and procedural complications
Thermal burn	1/16 (6.3%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukemia	1/16 (6.3%)	1
Other (Not Including Serious) Adverse Events
	Aortic Valve Repair
	Affected / at Risk (%)	# Events
Total	16/16 (100%)
Blood and lymphatic system disorders
Anaemia	3/16 (18.8%)	3
Thrombocytopenia	1/16 (6.3%)	1
Cardiac disorders
Aortic valve incompetence	1/16 (6.3%)	1
Arrhythmia	1/16 (6.3%)	1
Atrial fibrillation	3/16 (18.8%)	3
Pericardial effusion	1/16 (6.3%)	1
Tachycardia	1/16 (6.3%)	1
General disorders
Impaired healing	1/16 (6.3%)	1
Infections and infestations
Infection	1/16 (6.3%)	1
Investigations
Laboratory test abnormal	2/16 (12.5%)	2
Nervous system disorders
Paraesthesia	1/16 (6.3%)	1
Syncope	1/16 (6.3%)	1
Respiratory, thoracic and mediastinal disorders
Pleural effusion	2/16 (12.5%)	2
Skin and subcutaneous tissue disorders
Eczema	1/16 (6.3%)	1
Vascular disorders
Aortic dilation	1/16 (6.3%)	1
Aortic stenosis	2/16 (12.5%)	2
Haemorrhage	2/16 (12.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication by the investigator was not allowed until completion of the trial. All proposed publications must be cleared by unanimous vote of a publication committee consisting of the sponsor and representatives of the study investigators. Publication materials must be submitted for review at least 60 day in advance of publication. The Sponsor may embargo publication for 60 additional days to allow for patent filing or may prevent publication if filling of such application would be premature.