Aortic Aneurysm, Aortic Valve Insufficiency
Conditions
Keywords
aortic valve repair, aortic valve annuloplasty
Brief summary
Multicenter US registry study to assess procedure success and long-term (10-year) performance of the HAART 200 and HAART 300 Aortic Annuloplasty Devices when used during aortic valve repair in a routine cardiovascular practice setting.
Detailed description
The HAART Aortic Annuloplasty Devices are three-dimensional annuloplasty rings designed to be implanted intra-annularly in the aortic valve to correct annular dilatation and/or maintain annular geometry of the aortic valve in patients with trileaflet valve morphology (HAART 300) or bicuspid valve morphology (HAART 200) with moderate to severe aortic insufficiency who are undergoing aortic valve repair due to symptoms or as part of a repair for an aortic aneurysm. The study is a multicenter registry study enrolling both retrospective and prospective participants. Investigators are cardiothoracic surgeons specializing in surgery of the aortic valve and aorta at facilities with suitable infrastructure to support collection of the registry study data. Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device will be enrolled. All patients known to have received the HAART 300 or HAART 200 Device at participating centers will be contacted and offered the opportunity to enroll in this registry study. Prospective participants will have evaluations prior to surgery, intraoperatively, immediately following surgery, at discharge (or within 90 days), and at 1, 3, 5, and 10 years. In addition to the follow-up clinic visits, phone contacts are scheduled at years 2,4,6, 7, 8, and 9 to maintain participant engagement as well as to ascertain if any safety events have taken place. Retrospective participants who have already received the HAART 300 or HAART 200 Device prior to study enrollment will undergo safety assessment at the time of enrollment in the study.
Interventions
DEVICEAortic valve repair
Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery
Sponsors
Biostable Science & Engineering
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The patient underwent or is undergoing aortic valve repair using either the HAART 300 or HAART 200 Aortic Annuloplasty Device in accordance with the Instructions for Use. * The patient has reviewed and signed the written informed consent form. * The patient agrees to return for all follow-up evaluations for the duration of the study.
Exclusion criteria
* Retrospective patient that has undergone a subsequent aortic valve replacement procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from aortic valve reoperation | 10 years | A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure |
Other
| Measure | Time frame | Description |
|---|---|---|
| NYHA Functional Classification | 10 years | New York Hospital Association (NYHA) class: * Class I: cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea, or anginal pain. * Class II: cardiac disease resulting in slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea, or anginal pain. * Class III: cardiac disease resulting in marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. * Class IV: cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Aortic valve regurgitation grade | 10 years | The severity of aortic valve regurgitation expressed as the aortic regurgitation (AR) Grade (or Aortic insufficiency (AI) Grade). The grades are defined by the American Society of Echocardiography guidelines based on regurgitant volume (RVol), regurgitant fraction (RF), and effective regurgitant orifice area (EROA), and expressed as: 0 (None/trace) I (Mild: RVol \<30 mL, RF \<30%, EROA \<0.1 cm\*\*2) II (Mild-Moderate: RVol 30-44 mL, RF 30-39%, EROA 0.1-0.19 cm\*\*2) III (Moderate-Severe: RVol 45-59 mL, RF 40-49%, EROA 0.20.29 cm\*\*2) IV (Severe: RVol ≥60 mL, RF ≥50%, EROA ≥0.3 cm\*\*2). |
| Freedom from Cardiovascular Events | 10 years | Occurrence of any of the following events will be considered failure on this outcome measure. * Cardiac-related death * Aortic valve reintervention/reoperation * Major bleeding event * Structural valve deterioration * Nonstructural dysfunction * Operated valve endocarditis * Valve thrombosis * New permanent pacemaker or defibrillator within 14 days after the valve intervention * Embolism |
| All cause mortality | 10 years | Death due to any cause |
| Noncardiovascular serious adverse events | 10 years | Adverse events not of cardiovascular nature that led to death, resulted in a life-threatening illness or injury, resulted in hospitalization, or resulted in persistent or significant disability/incapacity. |
Countries
United States
Outcome results
None listed