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

History of Changes

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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

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.
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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

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]

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

Belgium

Germany

Aortic Valvular Regurgitation ^[1]
[Units: Participants]

^[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]

III

^[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

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1. Primary:

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

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2. Primary:

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

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3. Primary:

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

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4. Primary:

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

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5. Secondary:

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

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6. Secondary:

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

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7. Secondary:

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

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8. Secondary:

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

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9. Secondary:

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

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10. Secondary:

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

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11. Secondary:

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

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

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

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19. Secondary:

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

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

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

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23. Secondary:

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

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24. Secondary:

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

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25. Secondary:

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

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26. Secondary:

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

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27. Secondary:

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

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28. Secondary:

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

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29. Secondary:

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

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30. Secondary:

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

Show Outcome Measure 30

31. Secondary:

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

Show Outcome Measure 31

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

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):

Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nöbauer 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.

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.

Mazzitelli D, Stamm C, Rankin JS, Nöbauer 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.

Mazzitelli D, Nöbauer 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.

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

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