Clinical trial NCT00876525: Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Official title: Clinical Investigation of the Freedom SOLO Stentless Heart Valve
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Valve Diseases
Keywords: Heart diseases.
Aortic valve diseases.
Aortic valve insufficiency.
Aortic valve stenosis.
Lead sponsor: Corcym S.r.l
Sponsor class: INDUSTRY
First posted: 2009-04-06
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized, multicenter trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The complication and survival rates for the Freedom SOLO stentless valve.
timeFrame: up to 1 year
measure: The complication and survival rates for the Freedom SOLO stentless valve.
timeFrame: up to 5 year
Secondary outcomes:
measure: Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients
timeFrame: up to 5 year
measure: Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography
timeFrame: up to 5 year
measure: Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).
timeFrame: up to 5 year
measure: Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.
timeFrame: up to 5 year
measure: Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.
timeFrame: up to 5 year
measure: Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.
timeFrame: up to 5 year
measure: Preoperative and postoperative NYHA functional classifications
timeFrame: Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Krankenhaus Hietzing
city: Wien
country: Austria
facility: Medical University Vienna
city: Bruxelles
country: Belgium
facility: St. Luc Hospital
city: Gent
country: Belgium
facility: University Hospital Gent
city: Rennes
country: France
facility: Hôpital Pontchaillou - CHU
city: Tours
country: France
facility: Hôpital Trousseau - CHRU
city: Bad Neustadt An Der Saale
country: Germany
facility: Herz- und Gefäß-Klinik GmbH
city: Berlin
country: Germany
facility: Charité Hospital
city: Dresden
country: Germany
facility: Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Klinik für Herzchirurgie
city: Massa
country: Italy
facility: Ospedale del Cuore, Fondazione G. Monasterio
city: Treviso
country: Italy
facility: Ospedale "S. Maria di Ca' Foncello"
city: Udine
country: Italy
facility: Ospedale S. Maria Della Misericordia
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Eindhoven
country: Netherlands
facility: Catharina Hospital
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente, Thoraxcentrum
city: Nijmegen
country: Netherlands
facility: University Hospital St. Radboud
city: Porto
country: Portugal
facility: Hospital S. João
city: Bern
country: Switzerland
facility: Inselspital, University Hospital Berne
Study officials:
affiliation: KH Hietzing Wien
name: Markus Thalmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.