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Hemodynamic Comparison of Tissue Aortic Valves

NCT01635244 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-03

Study results available
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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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

Aortic valve replacement

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

Sponsors & Collaborators

Principal Investigators

  • David Bach, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01635244 on ClinicalTrials.gov