HAART Annuloplasty Device Valve Repair Registry

Aortic Aneurysm Clinical Trial

Official title:

Safety and Performance of Aortic Valve Repair Using the HAART Aortic Annuloplasty Devices - A Registry Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04035356
• Other study ID #: TP-01-045
• Status: Enrolling by invitation
• Start date: September 22, 2020
• Est. completion date: July 2035

Study information

• Verified date: February 2023
• Source: Biostable Science & Engineering
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 300
• Est. completion date: July 2035
• Est. primary completion date: July 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Valve Insufficiency

Intervention

Device:
• Aortic valve repair
Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Duke University	Durham	North Carolina
United States	Franciscan Health Indianapolis	Indianapolis	Indiana
United States	West Virginia University Heart & Vascular institute	Morgantown	West Virginia
United States	Missouri Baptist Medical Center	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Biostable Science & Engineering

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	NYHA Functional Classification	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.	10 years
Other	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
Other	Freedom from Cardiovascular Events	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	10 years
Other	All cause mortality	Death due to any cause	10 years
Other	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
Primary	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