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The study will be merged with another one.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAART 300 | HAART 300 Aortic Annuloplasty Device |
| |
| HAART 200 | HAART 200 Aortic Annuloplasty Device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aortic valve repair | Device | Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from aortic valve reoperation | A reintervention for repair or replacement of the aortic valve will be considered failure for this outcome measure | 10 years |
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| Measure | Description | Time Frame |
|---|---|---|
| NYHA Functional Classification | New York Hospital Association (NYHA) class:
|
Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent or will undergo aortic valve repair using either the HAART 300 or HAART 200 Device at participating centers.
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| Name | Affiliation | Role |
|---|---|---|
| J. Scott Rankin, MD | West Virginia University Heart and Vascular Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | United States | ||
| University of Michigan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26156945 | Background | Mazzitelli D, Fischlein T, Rankin JS, Choi YH, Stamm C, Pfeiffer S, Pirk J, Detter C, Kroll J, Beyersdorf F, Griffin CD, Shrestha M, Nobauer 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. | |
| 25865762 |
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| ID | Term |
|---|---|
| D001022 | Aortic Valve Insufficiency |
| D001014 | Aortic Aneurysm |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 10 years |
| Aortic valve regurgitation grade | 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). | 10 years |
| Freedom from Cardiovascular Events | Occurrence of any of the following events will be considered failure on this outcome measure.
| 10 years |
| All cause mortality | Death due to any cause | 10 years |
| Noncardiovascular serious adverse events | 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. | 10 years |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| West Virginia University Heart & Vascular institute | Morgantown | West Virginia | 26506 | United States |
| Background |
| Mazzitelli D, Pfeiffer S, Rankin JS, Fischlein T, Choi YH, Wahlers T, Nobauer C, Schreiber C, Lange R. A Regulated Trial of Bicuspid Aortic Valve Repair Supported by Geometric Ring Annuloplasty. Ann Thorac Surg. 2015 Jun;99(6):2010-6. doi: 10.1016/j.athoracsur.2015.01.050. Epub 2015 Apr 10. |
| 30138245 | Background | Rankin JS, Mazzitelli D, Fischlein T, Choi YH, Pirk J, Pfeiffer S, Wei LM, Badhwar V. Geometric Ring Annuloplasty for Aortic Valve Repair During Aortic Aneurysm Surgery: Two-Year Clinical Trial Results. Innovations (Phila). 2018 Jul/Aug;13(4):248-253. doi: 10.1097/IMI.0000000000000539. |
| D000783 |
| Aneurysm |
| D014652 | Vascular Diseases |
| D001018 | Aortic Diseases |