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Clinical Investigation of the Freedom SOLO Stentless Heart Valve | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

NCT00876525•Corcym S.r.l

Summary

This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Detailed Description

Freedom SOLO study is a prospective, non-randomized, multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement. The study was conducted at 18 centers in Europe. The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (OPCs). Based on the guidelines established by the U.S. Food and Drug Administration (FDA), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the OPC of 1.2 %/patient-year.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The patient is male or female 18 years old or older.
•The patient is willing to sign the informed consent.
•The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
•Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
•The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
•Patient will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria

•The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
•The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
•The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
•The patient has active endocarditis.
•The patient is or will be participating in a concomitant research study of an investigational product.
•The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
•The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
•The patient is pregnant or lactating.
•Patients with congenital bicuspid aortic valve.
•Patients are known to be noncompliant or are unlikely to complete the study.

Locations (19)

Krankenhaus Hietzing

Vienna, Austria

Medical University Vienna

Vienna, Austria

St. Luc Hospital

Brussels, Belgium

University Hospital Gent

Ghent, Belgium

Hôpital Pontchaillou - CHU

Rennes, France

Hôpital Trousseau - CHRU

Tours, France

Herz- und Gefäß-Klinik GmbH

Bad Neustadt an der Saale, Germany

Charité Hospital

Berlin, Germany

Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden

Dresden, Germany

Universitätsklinikum Erlangen, Klinik für Herzchirurgie

Erlangen, Germany

Key Dates

Start Date

March 1, 2009

Primary Completion Date

December 1, 2013

Completion Date

December 1, 2017

Last Updated

March 6, 2024

Enrollment

702

ACTUAL participants

Conditions

Heart Valve Diseases

Interventions

Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis

DEVICE

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

NCT05208567

Heart Valve DiseasesLeft Ventricular Dysfunction

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RECRUITINGNA

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

NCT03142152

Functional Mitral RegurgitationHeart Failure+4 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Inclusion Criteria

Exclusion Criteria

London Valvular Heart Disease and Reduced Ejection Fraction Detection in a Multi-ethnic Community Using Cardiac Ultrasound

The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With at Least Mild FMR

The Study of Biological Prosthetic Heart Valves With the "Easy Change" System

ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation

Interdisciplinary Perioperative Care in Minimally-invasive Heart Valve Surgery

An Exploratory Clinical Study to Evaluate the Safety and Efficacy of a Cardiac Surgical Cryoablation System for the Treatment of Atrial Fibrillation