Comparison of TrIfecta and Perimount Magna Ease

NCT ID: NCT03021356

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Xenograft Hemodynamics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trifecta aortic xenograft

The Trifecta aortic xenograft is implanted in these patients.

Group Type ACTIVE_COMPARATOR

Aortic xenograft

Intervention Type DEVICE

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

Magna Ease aortic xenograft

The Magna Ease aortic xenograft is implanted in these patients.

Group Type ACTIVE_COMPARATOR

Aortic xenograft

Intervention Type DEVICE

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

Interventions

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Aortic xenograft

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

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

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role collaborator

Kerckhoff Klinik

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kerckhoff Klinik

Bad Nauheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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COTRIP

Identifier Type: -

Identifier Source: org_study_id

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