NCT01732835

The HAART 300 Annuloplasty Ring Trial Extended Safety and Performance

The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Biostable Science & Engineering · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation is a prospective, non-randomized, multi-center trial to evaluate the extended safety and performance of the HAART model 300 annuloplasty ring when used to surgically repair the aortic valve using a 3-D intra-annular mounting frame.

Detailed description

Aortic Regurgitation, (also known as Aortic Insufficiency; AI), is the failure of the aortic valve to close completely during diastole which causes blood to flow from the aorta back into the left ventricle. Aortic Regurgitation (AR) is a frequent cause of both disability and death due to congestive heart failure, primarily in individuals forty or older, but can also occur in younger populations. Traditionally management of aortic regurgitation has been by aortic valve replacement, however, as has been observed in patients who have had mitral valve repair, the option of maintaining ones native aortic valve versus a replacement, either bioprosthetic or mechanical, can have added multiple benefits. The advantage of repair is the avoidance of prosthetic valve-related complications with bioprosthetic valves over 10-15 years or the need for anticoagulation with mechanical valves and the related problems of this therapy.

Conditions

• Aortic Insufficiency

Interventions

Type	Name	Description
DEVICE	HAART 300 Annuloplasty Device	Implantation of HAART 300 Annuloplasty Device for aortic valve repair

Timeline

• Start date: 2012-12-01
• Primary completion: 2014-06-01
• Completion: 2015-11-01
• First posted: 2012-11-26
• Last updated: 2017-03-10
• Results posted: 2017-01-31

Locations

8 sites across 2 countries: Czechia, Germany