Trial Outcomes & Findings for The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance (NCT NCT01732835)

NCT ID: NCT01732835

Last Updated: 2017-03-10

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 68 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-03-10

Participant Flow

Participant milestones

Measure	HAART 300 Annuloplasty Device Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
6-month Primary Endpoint STARTED	68
6-month Primary Endpoint COMPLETED	44
6-month Primary Endpoint NOT COMPLETED	24
2-year Extended Follow-up STARTED	44
2-year Extended Follow-up COMPLETED	39
2-year Extended Follow-up NOT COMPLETED	5

Reasons for withdrawal

Measure	HAART 300 Annuloplasty Device Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
6-month Primary Endpoint Did not receive device	19
6-month Primary Endpoint Withdrawal by Subject	2
6-month Primary Endpoint Adverse Event	3
2-year Extended Follow-up Withdrawal by Subject	1
2-year Extended Follow-up Adverse Event	3
2-year Extended Follow-up Death	1

Baseline Characteristics

Participants with an echocardiogram evaluable for this measure.

Baseline characteristics by cohort

Measure	HAART 300 Annuloplasty Device n=49 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
New York Heart Association (NYHA) Functional Capacity I	11 participants n=49 Participants
New York Heart Association (NYHA) Functional Capacity II	25 participants n=49 Participants
New York Heart Association (NYHA) Functional Capacity III	13 participants n=49 Participants
New York Heart Association (NYHA) Functional Capacity IV	0 participants n=49 Participants
Peak gradient	11.1 mm Hg STANDARD_DEVIATION 4.7 • n=43 Participants • Participants with an echocardiogram evaluable for this measure.
Mean gradient	5.5 mm Hg STANDARD_DEVIATION 2.4 • n=43 Participants • Participants with an echocardiogram evaluable for this measure.
Left ventricular (LV) mass	244.1 g STANDARD_DEVIATION 85.2 • n=39 Participants • Participants with an echocardiogram evaluable for this measure.
Left ventricular internal dimension (LVID) diastole	5.50 cm STANDARD_DEVIATION 0.86 • n=40 Participants • Participants with an echocardiogram evaluable for this measure.
LVID systole	4.02 cm STANDARD_DEVIATION 0.83 • n=35 Participants • Participants with an echocardiogram evaluable for this measure.
LV diastolic volume	155.3 ml STANDARD_DEVIATION 63.3 • n=27 Participants • Participants with an echocardiogram evaluable for this measure.
LV systolic volume	76.5 ml STANDARD_DEVIATION 37.7 • n=28 Participants • Participants with an echocardiogram evaluable for this measure.
Left ventricular ejection fraction (LVEF)	54.2 % STANDARD_DEVIATION 4.4 • n=27 Participants • Participants with an echocardiogram evaluable for this measure.
Cardiac output	6.20 l/min STANDARD_DEVIATION 2.17 • n=32 Participants • Participants with an echocardiogram evaluable for this measure.
Cardiac index	3.16 l/min/m^2 STANDARD_DEVIATION 1.11 • n=32 Participants • Participants with an echocardiogram evaluable for this measure.
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=49 Participants
Age, Categorical >=65 years	25 Participants n=49 Participants
Age, Continuous	61.0 years STANDARD_DEVIATION 13.6 • n=49 Participants
Sex: Female, Male Female	17 Participants n=49 Participants
Sex: Female, Male Male	32 Participants n=49 Participants
Region of Enrollment Czech Republic	5 participants n=49 Participants
Region of Enrollment Germany	44 participants n=49 Participants
Aortic Insufficiency 0	0 participants n=49 Participants
Aortic Insufficiency 1+	3 participants n=49 Participants
Aortic Insufficiency 2+	10 participants n=49 Participants
Aortic Insufficiency 3+	18 participants n=49 Participants
Aortic Insufficiency 4+	12 participants n=49 Participants
Aortic Insufficiency Not evaluable	6 participants n=49 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Measure	HAART 300 Annuloplasty Device n=49 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Primary Safety Outcome Measure: Survival Defined as Survival Free From All Cause Death at 6 Months Postprocedure	100 percentage of participants Interval 92.8 to 100.0

PRIMARY outcome

Timeframe: 6 months

Population: Participants with an echocardiogram evaluable for this measure.

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

Outcome measures

Measure	HAART 300 Annuloplasty Device n=41 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months 0	11 participants
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months 1+	21 participants
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months 2+	7 participants
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months 3+	2 participants
Primary Efficacy Outcome Measure: Aortic Insufficiency (AI) at 6 Months 4+	0 participants

SECONDARY outcome

Timeframe: discharge or 14 days postprocedure, whichever comes first

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 - 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.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=49 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Implant Procedure Success	95.9 percentage of implant procedures Interval 86.0 to 99.5

SECONDARY outcome

Timeframe: 6 months

Freedom from specified clinical cardiovascular events at 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

Outcome measures

Measure	HAART 300 Annuloplasty Device n=49 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Actuarial Freedom From Clinical Cardiovascular Events	89.6 percentage of participants Interval 80.9 to 98.4

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	HAART 300 Annuloplasty Device n=49 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Survival Defined as Survival Free From All Cause Death at 2 Years Postprocedure	97.6 percentage of participants Interval 83.9 to 99.7

SECONDARY outcome

Timeframe: 2 years

Population: Participants with an echocardiogram evaluable for this measure.

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

Outcome measures

Measure	HAART 300 Annuloplasty Device n=37 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Aortic Insufficiency (AI) at 2 Years 0	2 participants
Aortic Insufficiency (AI) at 2 Years 1+	25 participants
Aortic Insufficiency (AI) at 2 Years 2+	10 participants
Aortic Insufficiency (AI) at 2 Years 3+	0 participants
Aortic Insufficiency (AI) at 2 Years 4+	0 participants

SECONDARY outcome

Timeframe: 6 months

Population: Participants with an evaluation of this measure.

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

Outcome measures

Measure	HAART 300 Annuloplasty Device n=43 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months I	30 participants
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months II	13 participants
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months III	0 participants
New York Heart Association (NYHA) Functional Capacity Classification at 6 Months IV	0 participants

SECONDARY outcome

Timeframe: 2 years

Population: Participants with an evaluation of this measure.

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

Outcome measures

Measure	HAART 300 Annuloplasty Device n=38 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years I	28 participants
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years II	9 participants
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years III	1 participants
New York Heart Association (NYHA) Functional Capacity Classification at 2 Years IV	0 participants

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Transthoracic echocardiography parameter

Outcome measures

Measure	HAART 300 Annuloplasty Device n=36 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Peak Gradient - Change From Baseline	5.3 mm Hg Standard Deviation 6.7

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Transthoracic echocardiography parameter

Outcome measures

Measure	HAART 300 Annuloplasty Device n=34 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Peak Gradient - Change From Baseline	5.9 mm Hg Standard Deviation 10.7

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Transthoracic echocardiography parameter

Outcome measures

Measure	HAART 300 Annuloplasty Device n=36 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Mean Gradient - Change From Baseline	2.6 mm Hg Standard Deviation 3.7

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Transthoracic echocardiography parameter

Outcome measures

Measure	HAART 300 Annuloplasty Device n=34 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Mean Gradient - Change From Baseline	3.1 mm Hg Standard Deviation 5.3

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular mass. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=29 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Mass - Change From Baseline	-26.5 g Standard Deviation 60.0

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular mass. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=24 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Mass - Change From Baseline	-27.4 g Standard Deviation 60.8

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular internal dimension. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=30 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVID Diastole - Change From Baseline	-0.48 cm Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular internal dimension. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=24 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVID Diastole - Change From Baseline	-0.22 cm Standard Deviation 0.65

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular internal dimension. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=25 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVID Systole - Change From Baseline	-0.48 cm Standard Deviation 0.71

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular internal dimension. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=17 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVID Systole - Change From Baseline	-0.22 cm Standard Deviation 0.84

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular diastolic volume. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=16 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Diastolic Volume - Change From Baseline	-21.8 ml Standard Deviation 49.2

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular diastolic volume. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=18 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Diastolic Volume - Change From Baseline	-19.9 ml Standard Deviation 53.0

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular systolic volume. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=17 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Systolic Volume - Change From Baseline	-17.5 ml Standard Deviation 30.2

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular systolic volume. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=19 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LV Systolic Volume - Change From Baseline	-11.1 ml Standard Deviation 29.1

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Left ventricular ejection fraction. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=16 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVEF - Change From Baseline	2.49 percentage of blood volume Standard Error 7.65

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Left ventricular ejection fraction. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=18 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
LVEF - Change From Baseline	0.37 percentage of blood volume Standard Deviation 7.19

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Stroke volume x heart rate. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=22 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Cardiac Output - Change From Baseline	-1.15 l/min Standard Deviation 1.66

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Stroke volume x heart rate. Transthoracic echocardiography parameter.

Outcome measures

Measure	HAART 300 Annuloplasty Device n=20 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Cardiac Output - Change From Baseline	-0.50 l/min Standard Deviation 2.20

SECONDARY outcome

Timeframe: Baseline and 6 months

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

Hemodynamic parameter computed as cardiac output divided by body surface area

Outcome measures

Measure	HAART 300 Annuloplasty Device n=22 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Cardiac Index - Change From Baseline	-0.60 l/min/m^2 Standard Deviation 0.85

SECONDARY outcome

Timeframe: Baseline and 2 years

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

Hemodynamic parameter computed as cardiac output divided by body surface area

Outcome measures

Measure	HAART 300 Annuloplasty Device n=20 Participants Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Cardiac Index - Change From Baseline	-0.26 l/min/m^2 Standard Deviation 1.07

Adverse Events

HAART 300 Annuloplasty Device

Serious events: 23 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	HAART 300 Annuloplasty Device n=49 participants at risk Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Cardiac disorders angina pectoris	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders aortic insufficiency	10.2% 5/49 • Number of events 5 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders arrhythmia	8.2% 4/49 • Number of events 5 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders cardiac decompensation	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders pericardial effusion	8.2% 4/49 • Number of events 4 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders syncope	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Gastrointestinal disorders GI bleeding	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Gastrointestinal disorders reflux esophagitis	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Infections and infestations endocarditis	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Infections and infestations systemic inflammatory response syndrome	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Infections and infestations worsening of wound healing disorder	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Infections and infestations wound infection	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Injury, poisoning and procedural complications bleeding	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Injury, poisoning and procedural complications loosening of wire cerclages	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Injury, poisoning and procedural complications presternal abscess	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Musculoskeletal and connective tissue disorders lumbago	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Renal and urinary disorders renal failure	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders bronchopulmonary infection	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pleural effusion	4.1% 2/49 • Number of events 2 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pleuropneumonia	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pneumonia	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pneumothorax	6.1% 3/49 • Number of events 3 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pulmonary spasticity	2.0% 1/49 • Number of events 1 • Through 2 years for the 49 participants receiving the implant

Other adverse events

Measure	HAART 300 Annuloplasty Device n=49 participants at risk Implantation of HAART 300 Annuloplasty Device for aortic valve repair HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair
Blood and lymphatic system disorders anemia	10.2% 5/49 • Number of events 5 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders aortic insufficiency	14.3% 7/49 • Number of events 7 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders arrhythmia	40.8% 20/49 • Number of events 23 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders edema	10.2% 5/49 • Number of events 5 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders pericardial effusion	14.3% 7/49 • Number of events 7 • Through 2 years for the 49 participants receiving the implant
Cardiac disorders syncope	4.1% 2/49 • Number of events 3 • Through 2 years for the 49 participants receiving the implant
Endocrine disorders abnormal LDH value	4.1% 2/49 • Number of events 2 • Through 2 years for the 49 participants receiving the implant
Endocrine disorders hyperthyreosis	6.1% 3/49 • Number of events 3 • Through 2 years for the 49 participants receiving the implant
Infections and infestations increased C-reactive protein	12.2% 6/49 • Number of events 6 • Through 2 years for the 49 participants receiving the implant
Injury, poisoning and procedural complications bleeding event	6.1% 3/49 • Number of events 3 • Through 2 years for the 49 participants receiving the implant
Injury, poisoning and procedural complications sternal pain	6.1% 3/49 • Number of events 3 • Through 2 years for the 49 participants receiving the implant
Musculoskeletal and connective tissue disorders thoracic pain	4.1% 2/49 • Number of events 2 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders atelectasis	8.2% 4/49 • Number of events 4 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pleural effusion	28.6% 14/49 • Number of events 14 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders pneumothorax	12.2% 6/49 • Number of events 6 • Through 2 years for the 49 participants receiving the implant
Respiratory, thoracic and mediastinal disorders respiratory infection	4.1% 2/49 • Number of events 2 • Through 2 years for the 49 participants receiving the implant

Additional Information

John Wheeler

Biostable Science and Engineering, Inc.

Phone: 512-386-1996

Email: John.wheeler@biostable-s-e.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER