NCT03021356

Brief Summary

The hemodynamic performance of two supraannular aortic xenografts (Trifecta, St. Jude Medical and Perimount Magna Ease, Edwards Lifescience) will be compared using rest- and stress echocardiography in a randomized prospective study. Furthermore, the prostheses' influence on postoperative outcome will be compared using spiroergometry, quality of life questionnaire and heart failure biomarkers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.8 years

First QC Date

January 8, 2017

Last Update Submit

January 11, 2017

Conditions

Aortic Xenograft Hemodynamics

Outcome Measures

Primary Outcomes (1)

  • Transprosthetic pressure gradient at stress exercise echocardiography

    Echo at follow up stress echo (at 10 months)

Secondary Outcomes (4)

  • Transprosthetic pressure gradient at discharge echo

    Echo at discharge (usually postoperative day 5 to 7)

  • Left ventricular mass regression calculated by echocardiography (gram)

    Echo at discharge and at follow up (usually at postoperative day 5 to 7 and at 10 months)

  • Quality of life using the EQ-5D-3L questionnaire

    1 to 5 days before surgery and at follow up (10 months)

  • BNP plasma level

    1 to 5 days before surgery and at follow up (10 months)

Study Arms (2)

Trifecta aortic xenograft

ACTIVE COMPARATOR

The Trifecta aortic xenograft is implanted in these patients.

Device: Aortic xenograft

Magna Ease aortic xenograft

ACTIVE COMPARATOR

The Magna Ease aortic xenograft is implanted in these patients.

Device: Aortic xenograft

Interventions

Aortic xenograftDEVICE

After randomization, the aortic xenograft is implanted in the standard fashion

Magna Ease aortic xenograftTrifecta aortic xenograft

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between 18 and 75 years
  • Elective aortic valve replacement in patients with predominant aortic stenosis
  • including concomitant CABG and/or atrial fibrillation ablation and/or supracoronary aortic replacement
  • Informed consent including willingness for stress echocardiography, spiroergometry and quality of life examination after 6 months.
  • Native German speakers (quality of life questionnaire in German language)

You may not qualify if:

  • Isolated aortic regurgitation
  • Concomitant aortic regurgitation \> 2°
  • Endocarditis
  • LVEF \<40%
  • Concomitant other valve surgery
  • s/p valve surgery
  • Contraindication for stress echocardiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 13, 2017

Study Start

September 1, 2012

Primary Completion

July 1, 2014

Study Completion

August 1, 2016

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)