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HAART Model 300 Annuloplasty Ring

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biostable Science & Engineering
ClinicalTrials.gov Identifier:
NCT01400841
First received: July 21, 2011
Last updated: November 27, 2016
Last verified: November 2016
Results First Received: September 30, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Aortic Regurgitation
Intervention: Device: HAART 300 Annuloplasty Device

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
HAART 300 Annuloplasty Device

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair


Participant Flow for 2 periods

Period 1:   Initial Study Phase (6 Months)
    HAART 300 Annuloplasty Device
STARTED   16 [1] 
COMPLETED   15 
NOT COMPLETED   1 
Death                1 
[1] 2 of the 18 consented subjects did not receive the device

Period 2:   Extended Study Phase (2 Years)
    HAART 300 Annuloplasty Device
STARTED   13 [1] 
COMPLETED   11 
NOT COMPLETED   2 
Adverse Event                2 
[1]

1 subject refused further participation

1 subject death prior to agreeing to extended follow-up




  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
HAART 300 Annuloplasty Device

Implantation of HAART 300 Annuloplasty Device for aortic valve repair

HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair


Baseline Measures
   HAART 300 Annuloplasty Device 
Overall Participants Analyzed 
[Units: Participants]
 16 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      8  50.0% 
>=65 years      8  50.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.1  (9.3) 
Gender 
[Units: Participants]
Count of Participants
 
Female      3  18.8% 
Male      13  81.3% 
Region of Enrollment 
[Units: Participants]
 
Czech Republic   2 
Belgium   1 
Germany   13 
Aortic Valvular Regurgitation [1] 
[Units: Participants]
 
 0 
1+   0 
2+   6 
3+   7 
4+   3 
[1] Grade assigned to degree of aortic regurgitation determined by core laboratory analysis of echocardiogram: 0=None/trace, 1+=Mild, 2+=Moderate, 3+=Moderate-to-Severe, 4+=Severe
NYHA Classification [1] 
[Units: Participants]
 
 0 
II   10 
III   6 
IV   0 
[1]

New York Heart Association Functional Capacity

Class I: no limitation of activity. Ordinary activity - no undue fatigue, palpitation, dyspnea, or anginal pain.

Class II: slight limitation of activity. Comfortable at rest. Ordinary activity - fatigue, palpitation, dyspnea, or anginal pain.

Class III: marked limitation of activity. Comfortable at rest. Less than ordinary activity - fatigue, palpitation, dyspnea, or anginal pain.

Class IV: no activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. Increased discomfort upon activity.

Peak gradient [1] 
[Units: Mm Hg]
Mean (Standard Deviation)
 13.3  (6.2) 
[1] Echocardiographic parameter determined by core laboratory. n=14 (2 unavailable or not evaluable)
Mean gradient [1] 
[Units: Mm Hg]
Mean (Standard Deviation)
 6.8  (3.0) 
[1] Echocardiographic parameter determined by core laboratory. n=14 (2 unavailable or not evaluable)
Left ventricular (LV) mass [1] 
[Units: g]
Mean (Standard Deviation)
 260.0  (57.1) 
[1] Left ventricular mass. Echocardiographic parameter determined by core laboratory. n=11 (5 unavailable or not evaluable)
Left ventricular internal dimension (LVID) diastole [1] 
[Units: Cm]
Mean (Standard Deviation)
 5.44  (0.60) 
[1] Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. n=11 (5 unavailable or not evaluable)
LVID systole [1] 
[Units: Cm]
Mean (Standard Deviation)
 4.09  (0.76) 
[1] Left ventricular internal dimension. Echocardiographic parameter determined by core laboratory. n=7 (9 unavailable or not evaluable)
LV diastolic volume [1] 
[Units: Ml]
Mean (Standard Deviation)
 180.7  (50.2) 
[1] Left ventricular diastolic volume. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable)
LV systolic volume [1] 
[Units: Ml]
Mean (Standard Deviation)
 84.7  (25.4) 
[1] Left ventricular systolic volume. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable)
Left ventricular ejection fraction (LVEF) [1] 
[Units: %]
Mean (Standard Deviation)
 53.2  (6.7) 
[1] Left ventricular ejection fraction. Echocardiographic parameter determined by core laboratory. n=10 (6 unavailable or not evaluable)
Cardiac output [1] 
[Units: L/min]
Mean (Standard Deviation)
 6.77  (1.60) 
[1] Echocardiographic parameter determined by core laboratory. n=9 (7 unavailable or not evaluable)
Cardiac index [1] 
[Units: L/min/m^2]
Mean (Standard Deviation)
 3.41  (0.90) 
[1] Cardiac index is the cardiac output divided by body surface area. n=9 (7 unavailable or not evaluable)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Safety Outcome Measure: Event-free Survival   [ Time Frame: 1 month postprocedure ]

2.  Primary:   Primary Safety Outcome Measure: Event-free Survival   [ Time Frame: 2 years postprocedure (extended follow-up) ]

3.  Primary:   Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 6 Months Postprocedure   [ Time Frame: 6 months postprocedure ]

4.  Primary:   Primary Efficacy Outcome Measure: Aortic Valvular Regurgitation at 2 Years Postprocedure   [ Time Frame: 2 years postprocedure (extended follow-up) ]

5.  Secondary:   Implant Procedure Success   [ Time Frame: discharge or 14 days postprocedure, whichever comes first ]

6.  Secondary:   Implant Procedure Success   [ Time Frame: 2 years postprocedure (extended follow-up) ]

7.  Secondary:   Actuarial Freedom From Clinical Cardiovascular Events   [ Time Frame: 1 month postprocedure ]

8.  Secondary:   Actuarial Freedom From Clinical Cardiovascular Events   [ Time Frame: 2 years postprocedure ]

9.  Secondary:   Event-free Survival   [ Time Frame: 6 months postprocedure ]

10.  Secondary:   New York Heart Association (NYHA) Functional Capacity Classification   [ Time Frame: 6 months postprocedure ]

11.  Secondary:   New York Heart Association (NYHA) Functional Capacity Classification   [ Time Frame: 2 years postprocedure (extended follow-up) ]

12.  Secondary:   Peak Gradient - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

13.  Secondary:   Peak Gradient - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

14.  Secondary:   Mean Gradient - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

15.  Secondary:   Mean Gradient - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

16.  Secondary:   LV Mass - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

17.  Secondary:   LV Mass - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

18.  Secondary:   LVID Diastole - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

19.  Secondary:   LVID Diastole - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

20.  Secondary:   LVID Systole - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

21.  Secondary:   LVID Systole - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

22.  Secondary:   LV Diastolic Volume - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

23.  Secondary:   LV Diastolic Volume - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

24.  Secondary:   LV Systolic Volume - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

25.  Secondary:   LV Systolic Volume - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

26.  Secondary:   LVEF - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

27.  Secondary:   LVEF - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

28.  Secondary:   Cardiac Output - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

29.  Secondary:   Cardiac Output - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]

30.  Secondary:   Cardiac Index - Change From Baseline   [ Time Frame: Baseline, 6 months postprocedure ]

31.  Secondary:   Cardiac Index - Change From Baseline   [ Time Frame: Baseline, 2 years postprocedure (extended follow-up) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John Wheeler
Organization: Biostable Science and Engineering, Inc.
phone: 512-386-1996
e-mail: John.wheeler@biostable-s-e.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Biostable Science & Engineering
ClinicalTrials.gov Identifier: NCT01400841     History of Changes
Other Study ID Numbers: BSE 300
TP-01-013 ( Other Identifier: Biostable Science & Engineering, Inc )
TP-01-023 ( Other Identifier: Biostable Science & Engineering, Inc )
Study First Received: July 21, 2011
Results First Received: September 30, 2016
Last Updated: November 27, 2016