Hemodynamic Comparison of Tissue Aortic Valves

Aortic Valve Stenosis Clinical Trial

Official title:

Trifecta Comparative Stress Hemodynamic Study (Randomized Comparison of Exercise Hemodynamics and Left Ventricular Remodeling With Aortic Bioprostheses After Aortic Valve Replacement for Aortic Stenosis)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635244
• Other study ID #: N015029-00
• Status: Completed
• Phase: N/A
• First received: July 1, 2012
• Last updated: May 13, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: May 2016
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to:

1. Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves.

2. Assess for differences in left ventricular (LV) reverse remodeling (recovery of LV hypertrophy, and changes in LV systolic and diastolic function) after aortic valve replacement for severe aortic stenosis (AS) between three clinically available aortic valve bioprosthesis.

Description:

Various aortic valve prostheses have unique hemodynamic characteristics, and there is on-going interest in defining those hemodynamic characteristics in the interest of avoiding residual LV outflow obstruction and prosthesis-patient mismatch (residual LV outflow obstruction despite a normally functioning prosthesis ) after aortic valve replacement. Attempts to compare hemodynamics between prostheses have been limited by different sizing systems used by various manufacturers (precluding meaningful comparison of valves by valve size) and biological variability of in vivo gradients and effective orifice area for any valve (making potentially small differences in hemodynamics difficult to detect). Assessment of hemodynamics during increased cardiac output associated with exercise testing has been used to better define potentially subtle differences in hemodynamics between valve prostheses. In addition, assessment for change in LV geometry (notably including LV hypertrophy) after aortic valve replacement has been used as a surrogate marker of aortic prosthesis hemodynamics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age = 18 years.

• Severe aortic stenosis (AS) based on overall clinical impression, with or without aortic valve mean gradient = 40 mm Hg, EOA < 1.0 cm2, or EOA index < 0.6 cm2/m2.

• Scheduled for clinically indicated elective aortic valve replacement for a primary diagnosis of severe AS.

• Less than moderate aortic regurgitation on preoperative testing.

• Isolated aortic valve replacement; or aortic valve replacement with concomitant coronary artery bypass grafting, ascending aorta repair, or mitral and/or tricuspid annuloplasty for functional mitral regurgitation / tricuspid regurgitation.

• Left ventricular ejection fraction = 40% on preoperative testing.

• Physically able and willing to pedal a recumbent bicycle.

• Patient and surgeon agree that the patient will undergo valve replacement with a bioprosthesis.

• Patient and surgeon agree that the use of one specific bioprosthesis manufacturer / model is not indicated based on clinical criteria.

• Willing to undergo randomization to have implanted one of three bioprosthesis at the time of aortic valve replacement.

• Willing and able to undergo preoperative echocardiography/Doppler for purposes of the research study.

• Willing and able to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.

Exclusion Criteria:

• Age < 18 years.

• AS felt by overall clinical impression to be less than severe.

• Aortic valve replacement is urgent or emergent.

• Moderate of more aortic regurgitation on preoperative testing.

• Concomitant mitral or tricuspid valve replacement.

• Left ventricular ejection fraction < 40% on preoperative testing.

• Physically unable or unwilling to pedal a recumbent bicycle.

• Planned aortic valve replacement with a mechanical prosthesis.

• Operating surgeon believes that any one of the three protocol bioprosthetic devices is contraindicated based on clinical criteria.

• Not willing to undergo randomization to have implanted one of three bioprosthesis.

• Unwilling or unable to undergo preoperative echocardiography/Doppler for purposes of the research protocol.

• Unwilling or unable to undergo post-operative exercise stress echocardiography/Doppler 5 to 7 months after valve replacement for purposes of the research protocol.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Ventricular Remodeling

Intervention

Device:
• Aortic valve replacement
Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).

Locations

Country	Name	City	State
United States	University of Michigan Health Systems	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic valve mean gradient (mm Hg) at peak exercise	This is a measure of the resistance to flow across the aortic bioprosthesis.	6 months after aortic valve replacement	No
Secondary	Aortic valve stroke work index	This is a measure of the work that the left ventricle does during systole, and incorporates the hemodynamic load of any residual aortic stenosis associated with the implanted bioprosthesis.	6 months after aortic valve replacement	No
Secondary	Change in LV diastolic strain	This is a measure of LV diastolic function (relaxation of the LV), and will include global longitudinal and circumferential early diastolic strain.	Up to 4 weeks before valve replacement , 6 months after aortic valve replacement	No