Hemodynamic Comparison of Tissue Aortic Valves

NCT01635244 | Completed Results

• 1 other identifier: N015029-00
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 1.Assess for hemodynamic differences at rest and with exercise between three clinically available tissue aortic valves.
2. 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.

Conditions

Aortic Valve Stenosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Freestyle

ACTIVE COMPARATOR

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

Device: Aortic valve replacement

Magna Ease

ACTIVE COMPARATOR

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

Device: Aortic valve replacement

Trifecta

ACTIVE COMPARATOR

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

Device: Aortic valve replacement

Interventions

Aortic valve replacement DEVICE

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

Freestyle; Magna Ease; Trifecta

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Health Systems

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 26819292 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis; Ventricular Remodeling

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Results Point of Contact

• Title: David Bach, MD
• Organization: University of Michigan

dbach@med.umich.edu

734-615-4907

Study Officials

• David Bach, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: July 1, 2012
• First Posted: July 9, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 3, 2017
• Results First Posted: February 3, 2017

Record last verified: 2016-12

Locations

US (1)