Clinical Investigation of the Freedom SOLO Stentless Heart Valve

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT00876525
First received: April 3, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Heart Valve Diseases
Device: Freedom SOLO

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • The complication and survival rates for the Freedom SOLO stentless valve. [ Time Frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemodynamic performance of the Freedom SOLO stentless valve. Clinically significant improvement in overall patient condition. [ Time Frame: Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion. ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: March 2009
Estimated Study Completion Date: September 2017
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Freedom SOLO stentless valve Device: Freedom SOLO
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00876525

Locations
Austria
Krankenhaus Hietzing
Wien, Austria, 1030
Medical University Vienna
Wien, Austria, 1090
Belgium
St. Luc Hospital
Bruxelles, Belgium, 1200
University Hospital Gent
Gent, Belgium, 9000
France
Hôpital Pontchaillou - CHU
Rennes, France, 35033
Hôpital Trousseau - CHRU
Tours, France, 37000
Germany
Herz- und Gefäß-Klinik GmbH
Bad Neustadt, Germany, 97616
Charité Hospital
Berlin, Germany, 10117
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
Dresden, Germany, 01307
Universitätsklinikum Erlangen, Klinik für Herzchirurgie
Erlangen, Germany, 91054
Italy
Ospedale del Cuore, Fondazione G. Monasterio
Massa, Italy, 54100
Ospedale "S. Maria di Ca' Foncello"
Treviso, Italy, 31100
Ospedale S. Maria Della Misericordia
Udine, Italy, 33100
Netherlands
Academisch Medisch Centrum
Amsterdam, Netherlands, 1100 DD
Catharina Hospital
Eindhoven, Netherlands, 5623 EJ
Medisch Spectrum Twente, Thoraxcentrum
Enschede, Netherlands, 7513 ER
University Hospital St. Radboud
Nÿmegen, Netherlands, 6500 HB
Portugal
Hospital S. João
Porto, Portugal, 4200-319
Switzerland
Inselspital, University Hospital Berne
Bern, Switzerland, 3010
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Markus Thalmann, MD KH Hietzing Wien
  More Information

No publications provided

Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT00876525     History of Changes
Other Study ID Numbers: V10604
Study First Received: April 3, 2009
Last Updated: June 4, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Dutch Health Care Inspectorate
Portugal: National Pharmacy and Medicines Institute

Keywords provided by Sorin Group:
Heart diseases.
Aortic valve diseases.
Aortic valve insufficiency.
Aortic valve stenosis.

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014