Hemodynamic Comparison of Tissue Aortic Valves

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01635244
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 3
• Duration (Months): 41
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Aortic valve replacement	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: Jul 1, 2012
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Freestyle Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).	Device: Aortic valve replacement; Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
Active Comparator: Magna Ease Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).	Device: Aortic valve replacement; Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
Active Comparator: Trifecta Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).	Device: Aortic valve replacement; Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).

Outcome Measures

Primary Outcome Measures

1. Aortic Valve Mean Gradient (mm Hg) at Peak Exercise [6 months after aortic valve replacement]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan Health Systems	Ann Arbor	Michigan	United States	48109

Sponsors and Collaborators

• University of Michigan

Investigators

• Principal Investigator: David Bach, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: David Bach, MD, Professor of Medicine, University of Michigan
• ClinicalTrials.gov Identifier: NCT01635244
• Other Study ID Numbers: N015029-00
• First Posted: Jul 9, 2012
• Last Update Posted: Feb 3, 2017
• Last Verified: Dec 1, 2016

• Keywords provided by David Bach, MD, Professor of Medicine, University of Michigan: Aortic valve prosthesis; Aortic valve hemodynamics; Prosthesis-patient mismatch; Left ventricular diastolic function; Left ventricular remodeling
• Additional relevant MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic; Ventricular Remodeling

Study Results

Participant Flow

Arm/Group Title	Freestyle	Magna Ease	Trifecta
Arm/Group Description	Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
Period Title: Overall Study
STARTED	18	22	20
COMPLETED	17	21	18
NOT COMPLETED	1	1	2

Baseline Characteristics

Arm/Group Title	Freestyle	Magna Ease	Trifecta	Total
Arm/Group Description	Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Total of all reporting groups
Overall Participants	17	21	18	56
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	74	67	71	70
Gender (Count of Participants)
Female	6 35.3%	9 42.9%	4 22.2%	19 33.9%
Male	11 64.7%	12 57.1%	14 77.8%	37 66.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	0 0%
Not Hispanic or Latino	16 94.1%	21 100%	17 94.4%	54 96.4%
Unknown or Not Reported	1 5.9%	0 0%	1 5.6%	2 3.6%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%
White	16 94.1%	21 100%	17 94.4%	54 96.4%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 5.9%	0 0%	1 5.6%	2 3.6%
Region of Enrollment (participants) [Number]
United States	17 100%	21 100%	18 100%	56 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freestyle	Magna Ease	Trifecta
Arm/Group Description	Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).	Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
Measure Participants	17	21	18
Median (Inter-Quartile Range) [mm Hg]	11	14	11

Adverse Events

Arm/Group Title	Freestyle		Magna Ease		Trifecta
Arm/Group Description	Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).		Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).		Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN). Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
All Cause Mortality
	Freestyle		Magna Ease		Trifecta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Freestyle		Magna Ease		Trifecta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Freestyle		Magna Ease		Trifecta
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/22 (0%)		0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.