Clinical Investigation of the Freedom SOLO Stentless Heart Valve

NCT00876525 | Completed DMC

• 1 other identifier: V10604
• Study Type: interventional
• Target: 702
• Locations: 8 countries
• Sites: 19

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.

Conditions

Heart Valve Diseases

Keywords

Heart diseases.; Aortic valve diseases.; Aortic valve insufficiency.; Aortic valve stenosis.

Outcome Measures

Primary Outcomes (2)

• The complication and survival rates for the Freedom SOLO stentless valve.

  Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.

  up to 1 year

• The complication and survival rates for the Freedom SOLO stentless valve.

  Safety of the Freedom SOLO was evaluated based on the following adverse events related to cardiac valve replacement: valve thrombosis, thromboembolism, bleeding, anticoagulant-related bleeding, paravalvular leak, endocarditis, clinically significant hemolysis, nonstructural dysfunction, structural valve deterioration, reoperation, explant, and death.

  up to 5 year

Secondary Outcomes (7)

• Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients

  up to 5 year

• Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography

  up to 5 year

• Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).

  up to 5 year

• Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.

  up to 5 year

• Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.

  up to 5 year

Study Arms (1)

Freedom SOLO stentless valve

OTHER

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

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

Interventions

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

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

Freedom SOLO stentless valve

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
• 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.

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (19)

Krankenhaus Hietzing

Vienna, 1030, Austria

Location

Medical University Vienna

Vienna, 1090, Austria

Location

St. Luc Hospital

Brussels, 1200, Belgium

Location

University Hospital Gent

Ghent, 9000, Belgium

Location

Hôpital Pontchaillou - CHU

Rennes, 35033, France

Location

Hôpital Trousseau - CHRU

Tours, 37000, France

Location

Herz- und Gefäß-Klinik GmbH

Bad Neustadt an der Saale, 97616, Germany

Location

Charité Hospital

Berlin, 10117, Germany

Location

Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden

Dresden, 01307, Germany

Location

Universitätsklinikum Erlangen, Klinik für Herzchirurgie

Erlangen, 91054, Germany

Location

Ospedale del Cuore, Fondazione G. Monasterio

Massa, 54100, Italy

Location

Ospedale "S. Maria di Ca' Foncello"

Treviso, 31100, Italy

Location

Ospedale S. Maria Della Misericordia

Udine, 33100, Italy

Location

Academisch Medisch Centrum

Amsterdam, 1100 DD, Netherlands

Location

Catharina Hospital

Eindhoven, 5623 EJ, Netherlands

Location

Medisch Spectrum Twente, Thoraxcentrum

Enschede, 7513 ER, Netherlands

Location

University Hospital St. Radboud

Nijmegen, 6500 HB, Netherlands

Location

Hospital S. João

Porto, 4200-319, Portugal

Location

Inselspital, University Hospital Berne

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 26443880 RESULT

MeSH Terms

Conditions

Heart Valve Diseases; Heart Diseases; Aortic Valve Disease; Aortic Valve Insufficiency; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Officials

• Markus Thalmann, MD

  KH Hietzing Wien

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, multicenter trial

Study Record Dates

• First Submitted: April 3, 2009
• First Posted: April 6, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2017
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); FR (2); NL (4); AU (2); BE (2); DE (4); CH (1); PT (1)