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Clinical Investigation of the Freedom SOLO Stentless Heart Valve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00876525
Recruitment Status : Unknown
Verified November 2016 by LivaNova.
Recruitment status was:  Active, not recruiting
First Posted : April 6, 2009
Last Update Posted : December 1, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Heart Valve Diseases Device: Freedom SOLO Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Study Start Date : March 2009
Actual Primary Completion Date : December 2013
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Experimental: Freedom SOLO stentless valve Device: Freedom SOLO
The Freedom SOLO heart valve prosthesis is a stentless bioprosthesis manufactured with bovine pericardium.

Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00876525

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Krankenhaus Hietzing
Wien, Austria, 1030
Medical University Vienna
Wien, Austria, 1090
St. Luc Hospital
Bruxelles, Belgium, 1200
University Hospital Gent
Gent, Belgium, 9000
Hôpital Pontchaillou - CHU
Rennes, France, 35033
Hôpital Trousseau - CHRU
Tours, France, 37000
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
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
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
Hospital S. João
Porto, Portugal, 4200-319
Inselspital, University Hospital Berne
Bern, Switzerland, 3010
Sponsors and Collaborators
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Principal Investigator: Markus Thalmann, MD KH Hietzing Wien

Publications of Results:
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Responsible Party: LivaNova Identifier: NCT00876525     History of Changes
Other Study ID Numbers: V10604
First Posted: April 6, 2009    Key Record Dates
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by LivaNova:
Heart diseases.
Aortic valve diseases.
Aortic valve insufficiency.
Aortic valve stenosis.

Additional relevant MeSH terms:
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Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action