Comparison of Two Pericardial Bioprostheses in AVR

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-23

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the study is to compare early and 1-year hemodynamic performance and clinical outcomes after aortic valve replacement using two pericardial bioprosthesis, Avalus and Carpentier Edwards Perimount Magna Ease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis

NCT03976817

Aortic Valve Disease Prosthesis; Cardiac, Heart, Functional Disturbance as Result

COMPLETED

REpositionable Versus BallOOn-expandable Prosthesis for Trans-catheter Aortic Valve Implantation

NCT02668484

Aortic Valve Disease

COMPLETED NA

Perceval Aortic Bioprostheses : Durability Study.

NCT07116265

Stenoses, Aortic Valve Aortic Insufficiency Aortic Diseases

COMPLETED

Early Feasibility Study of Surgical Implantation of a Polymer Prosthetic Mitral and Aortic Valve

NCT07097740

AORTIC VALVE DISEASES Mitral Valve Disease Aortic Stenosis +3 more

RECRUITING NA

Comparison Between Three Types of Stented Pericardial Aortic Valves

NCT01522352

Aortic Valve Replacement

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This trial was designed as a multicenter randomized, controlled trial to recruit 386 patients who undergo aortic valve replacement with pericardial bioprosthesis. Patients were randomized by use of a randomization table. Bioprosthesis was chosen between Avalus or Carpentier Edwards Perimount Magna Ease according to the randomization result. The primary end point is postoperative 1-year transvalvular mean pressure gradient. The secondary end points are postoperative 1-year effective orifice area, operative mortality, operative morbidities, 1-year overall survival, 1-year freedom from cardiac death and 1-year freedom from valve-related events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Valve Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AVALUS group

patients who will undergo aortic valve replacement with Avalus bioprosthesis

Group Type EXPERIMENTAL

AVR with AVALUS

Intervention Type DEVICE

aortic valve replacement with AVALUS bioprosthesis

CEPME group

patients who will undergo aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Group Type ACTIVE_COMPARATOR

AVR with CEPME

Intervention Type DEVICE

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AVR with AVALUS

aortic valve replacement with AVALUS bioprosthesis

Intervention Type DEVICE

AVR with CEPME

aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients who are going to undergo aortic valve replacement with bioprosthesis

Exclusion Criteria

* heart failure with severe LV dysfunction (LV EF \<30%)
* active infective endocarditis
* with other critical cardiovascular disease (e.g. acute aortic dissection)
* with other critical comorbities by which the expected life span is less than 1 year
* inadequate participant by the researcher's discretion

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No