Back to results

Hemodynamic Comparison of Tissue Aortic Valves

Primary Purpose

Aortic Valve Stenosis

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Aortic valve replacement

About this trial

This is an interventional prevention trial for Aortic Valve Stenosis focused on measuring Aortic valve prosthesis, Aortic valve hemodynamics, Prosthesis-patient mismatch, Left ventricular diastolic function, Left ventricular remodeling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Michigan Health Systems

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Freestyle

Magna Ease

Trifecta

Arm Description

Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).

Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).

Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).

Outcomes

Primary Outcome Measures

Aortic Valve Mean Gradient (mm Hg) at Peak Exercise

This is a measure of the resistance to flow across the aortic bioprosthesis.

Secondary Outcome Measures

Full Information

NCT ID

NCT01635244

First Posted

July 1, 2012

Last Updated

December 10, 2016

Sponsor

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT01635244

Brief Title

Hemodynamic Comparison of Tissue Aortic Valves

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to: Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves. 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Valve Stenosis

Keywords

Aortic valve prosthesis, Aortic valve hemodynamics, Prosthesis-patient mismatch, Left ventricular diastolic function, Left ventricular remodeling

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Freestyle

Arm Type

Active Comparator

Arm Description

Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).

Arm Title

Magna Ease

Arm Type

Active Comparator

Arm Description

Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).

Arm Title

Trifecta

Arm Type

Active Comparator

Arm Description

Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).

Intervention Type

Device

Intervention Name(s)

Aortic valve replacement

Intervention Description

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

Primary Outcome Measure Information:

Title

Aortic Valve Mean Gradient (mm Hg) at Peak Exercise

Description

This is a measure of the resistance to flow across the aortic bioprosthesis.

Time Frame

6 months after aortic valve replacement

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Bach, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan Health Systems

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26819292

Citation

Bach DS, Patel HJ, Kolias TJ, Deeb GM. Randomized comparison of exercise haemodynamics of Freestyle, Magna Ease and Trifecta bioprostheses after aortic valve replacement for severe aortic stenosis. Eur J Cardiothorac Surg. 2016 Aug;50(2):361-7. doi: 10.1093/ejcts/ezv493. Epub 2016 Jan 27.

Results Reference

derived

Learn more about this trial

Hemodynamic Comparison of Tissue Aortic Valves

We'll reach out to this number within 24 hrs