Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Information source: Sorin Group
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Valve Diseases
Intervention: Freedom SOLO (Device)
Phase: N/A
Status: Recruiting
Sponsored by: Sorin Group Official(s) and/or principal investigator(s):
Sven Beholz, MD, PhD, Principal Investigator, Affiliation: Charitè Hospital Berlin
Overall contact:
Michele Nozza, Phone: 0039 0161 487959, Email: michele.nozza@sorin.com
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.
Clinical Details
Official title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The complication and survival rates for the Freedom SOLO stentless valve.
Secondary outcome: Hemodynamic performance of the Freedom SOLO stentless valve. Clinically significant improvement in overall patient condition.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Michele Nozza, Phone: 0039 0161 487959, Email: michele.nozza@sorin.com
Krankenhaus Hietzing, Wien 1030, Austria; Recruiting
Markus Thalmann, MD, Phone: 0043 1801102392, Email: markus.thalmann@wienkav.at
Markus Thalmann, MD, Principal Investigator
Medical University Vienna, Wien 1090, Austria; Active, not recruiting
St. Luc Hospital, Bruxelles 1200, Belgium; Recruiting
Gebrine El Khoury, MD, Phone: 0032 27646107, Email: gebrine.elkhoury@uclouvain.be
Gebrine El Khoury, MD, Principal Investigator
University Hospital Gent, Gent 9000, Belgium; Recruiting
Katrien François, MD FETCS, Phone: 0032 93324711, Email: katrien.francois@ugent.be
Katrien François, MD FETCS, Principal Investigator
Hôpital Pontchaillou - CHU, Rennes 35033, France; Recruiting
Alain Leguerrier, MD, Phone: 0033 299282473, Email: alain.leguerrier@chu-rennes.fr
Alain Leguerrier, MD, Principal Investigator
Hôpital Trousseau - CHRU, Tours 37000, France; Recruiting
Michel Aupart, MD, Phone: 0033 247475918, Email: aupart@med.univ-tours.fr
Michel Aupart, MD, Principal Investigator
Herz- und Gefäß-Klinik GmbH, Bad Neustadt 97616, Germany; Active, not recruiting
Charité Hospital, Berlin 10117, Germany; Recruiting
Herko Grubitzsch, MD, Phone: 0049 30 450522092, Email: herko.grubitzsch@charite.de
Herko Grubitzsch, MD, Principal Investigator
Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden, Dresden 01307, Germany; Recruiting
Klaus Matschke, MD, Phone: 0049 351 450 1801, Email: K.Matschke@herzzentrum-dresden.com
Klaus Matschke, MD, Principal Investigator
Universitätsklinikum Erlangen, Klinik für Herzchirurgie, Erlangen 91054, Germany; Active, not recruiting
Ospedale del Cuore, Fondazione G. Monasterio, Massa 54100, Italy; Recruiting
Mattia Glauber, MD, Phone: 0039 0585 493604, Email: glauber@ifc.cnr.it
Mattia Glauber, MD, Principal Investigator
Ospedale "S. Maria di Ca' Foncello", Treviso 31100, Italy; Recruiting
Francesco Cesari, MD, Phone: 0039 0422 322633, Email: fcesari@ulss.tv.it
Francesco Cesari, MD, Principal Investigator
Ospedale S. Maria Della Misericordia, Udine 33100, Italy; Recruiting
Ugolino Livi, MD, Phone: 0039 0432552430, Email: livi.ugo@aoud.sanita.fvg.it
Ugolino Livi, MD, Principal Investigator
Academisch Medisch Centrum, Amsterdam 1100 DD, Netherlands; Active, not recruiting
Catharina Hospital, Eindhoven 5623 EJ, Netherlands; Active, not recruiting
Medisch Spectrum Twente, Thoraxcentrum, Enschede 7513 ER, Netherlands; Recruiting
Abel G. Hensens, MD, Phone: 0031 534876159, Email: a.hensens@ziekenhuis-mst.nl
Abel G. Hensens, MD, Principal Investigator
University Hospital St. Radboud, Nÿmegen 6500 HB, Netherlands; Active, not recruiting
Hospital S. João, Porto 4200-319, Portugal; Recruiting
Mário Jorge Amorim, MD, Phone: 00351 913805279, Email: mjgsmamorim@hotmail.com
Mario Jorge Amorim, MD, Principal Investigator
Inselspital, University Hospital Berne, Bern 3010, Switzerland; Active, not recruiting
Additional Information
Starting date: March 2009
Last updated: March 24, 2011
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