CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
Aortic valve replacementdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01635244
NCT01635244N/ACompleted
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Trifecta Comparative Stress Hemodynamic Study (Randomized Comparison of Exercise Hemodynamics and Left Ventricular Remodeling With Aortic Bioprostheses After Aortic Valve Replacement for Aortic Stenosis)

University of Michigan·interventional·Posted Jul 9, 2012·Updated Feb 3, 2017

In Brief

A clinical study evaluating Aortic valve replacement for Aortic Valve Stenosis. Completed, enrolled 60 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 9, 2012
Enrollment StartJul 1, 2012
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 14.0 years ago

Interventions

Aortic valve replacementdevice

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