Clinical Investigation of the Freedom SOLO Stentless Heart Valve

NCT ID: NCT00876525

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 702 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2017-12-31

Brief 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.

Conditions

Heart Valve Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Freedom SOLO stentless valve

Prospective data collection on the outcomes in patients treated with the CE Marked Freedom Solo Valve within the approved indication.

Group Type: OTHER

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

Intervention Type: DEVICE

The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.

Interventions

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

The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corcym S.r.l

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Thalmann, MD

Role: PRINCIPAL_INVESTIGATOR

KH Hietzing Wien

Locations

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

Ospedale del Cuore, Fondazione G. Monasterio

Massa, , Italy

Ospedale "S. Maria di Ca' Foncello"

Treviso, , Italy

Ospedale S. Maria Della Misericordia

Udine, , Italy

Academisch Medisch Centrum

Amsterdam, , Netherlands

Catharina Hospital

Eindhoven, , Netherlands

Medisch Spectrum Twente, Thoraxcentrum

Enschede, , Netherlands

University Hospital St. Radboud

Nijmegen, , Netherlands

Hospital S. João

Porto, , Portugal

Inselspital, University Hospital Berne

Bern, , Switzerland

Countries

Austria; Belgium; France; Germany; Italy; Netherlands; Portugal; Switzerland

References

Thalmann M, Grubitzsch H, Matschke K, Glauber M, Tan E, Francois K, Amorim MJ, Hensens AG, Cesari F, Feyrer R, Diegeler A, Veit F, Repossini A; Freedom Solo Investigators. A European Multicenter Study of 616 Patients Receiving the Freedom Solo Stentless Bioprosthesis. Ann Thorac Surg. 2016 Jan;101(1):100-8. doi: 10.1016/j.athoracsur.2015.06.096. Epub 2015 Oct 9.

Reference Type: RESULT

PMID: 26443880 (View on PubMed)

Other Identifiers

V10604

Identifier Type: -

Identifier Source: org_study_id