HAART 200 Aortic Valve Annuloplasty Trial

Status Completed

Clinical Trial 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).

Clinical Trial 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02071849
Study type	Interventional
Source	Biostable Science & Engineering
Contact
Status	Completed
Phase	N/A
Start date	September 2013
Completion date	August 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02629328` - CardioCel Tri-leaflet Repair Study	N/A
Completed	`NCT05002088` - Portico Valve-in-Valve Retrospective Registry
Recruiting	`NCT05171712` - Portico and Navitor India Clinical Trial	N/A
Completed	`NCT01598844` - JUPITER Study: Transapical Aortic Valve Implantation for Aortic Regurgitation
Active, not recruiting	`NCT04415047` - The JenaValve ALIGN-AR Pivotal Trial	N/A
Not yet recruiting	`NCT06377449` - Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients	N/A
Recruiting	`NCT04178213` - First in Human Feasibility Study With ADAPT 3D - ALR for Aortic Leaflet Repair	N/A
Completed	`NCT04489095` - Conduction Disease After Transcatheter Aortic Valve Replacement	N/A
Active, not recruiting	`NCT01456975` - Extravalvular Procedure for Surgical Treatment of Ascending Aorta Aneurism	N/A
Terminated	`NCT02058134` - The CardioPAT Project: A Randomized Trial	N/A
Completed	`NCT01732835` - The HAART 300 Annuloplasty Ring Extended Safety and Performance Trial Used in Surgical Repair of the Aortic Valve	N/A
Completed	`NCT01115907` - Freedom SOLO Stentless Heart Valve Study	Phase 3
Completed	`NCT03600051` - Automated Phonocardiography Analysis in Adults
Not yet recruiting	`NCT05424653` - To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Insufficiency	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.