Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Heart Valve Diseases Clinical Trial

Official title:

Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00876525
• Other study ID #: V10604
• Status: Completed
• Phase: N/A
• Start date: March 2009
• Est. completion date: December 2017

Study information

• Verified date: March 2024
• Source: Corcym S.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 702
• Est. completion date: December 2017
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• Surgical Replacement of the diseased native aortic heart valve with the Freedom SOLO Valve prosthesis
The Freedom SOLO prosthesis is designed for implantation in a supra-annular, sub-coronary position, with a single suture line.

Locations

Country	Name	City	State
Austria	Krankenhaus Hietzing	Wien
Austria	Medical University Vienna	Wien
Belgium	St. Luc Hospital	Bruxelles
Belgium	University Hospital Gent	Gent
France	Hôpital Pontchaillou - CHU	Rennes
France	Hôpital Trousseau - CHRU	Tours
Germany	Herz- und Gefäß-Klinik GmbH	Bad Neustadt An Der Saale
Germany	Charité Hospital	Berlin
Germany	Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden	Dresden
Germany	Universitätsklinikum Erlangen, Klinik für Herzchirurgie	Erlangen
Italy	Ospedale del Cuore, Fondazione G. Monasterio	Massa
Italy	Ospedale "S. Maria di Ca' Foncello"	Treviso
Italy	Ospedale S. Maria Della Misericordia	Udine
Netherlands	Academisch Medisch Centrum	Amsterdam
Netherlands	Catharina Hospital	Eindhoven
Netherlands	Medisch Spectrum Twente, Thoraxcentrum	Enschede
Netherlands	University Hospital St. Radboud	Nijmegen
Portugal	Hospital S. João	Porto
Switzerland	Inselspital, University Hospital Berne	Bern

Sponsors (1)

Lead Sponsor	Collaborator
Corcym S.r.l

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Portugal,  Switzerland, 

References & 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 B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Hemodynamic performance of the Freedom SOLO stentless valve: transvalvular peak and mean pressure gradients	Decrease of transvalvular peak and mean pressure gradients from preoperative to follow up	up to 5 year
Secondary	Hemodynamic performance of the Freedom SOLO stentless valve: effective orifice area (EOA) in cm2 by transthoracic echocardiography	Increase of effective orifice area (EOA) from preoperative to follow up	up to 5 year
Secondary	Hemodynamic performance of the Freedom SOLO stentless valve: EOA index (EOAI cm2/m2).	Increase of effective orifice area index from preoperative to follow up.	up to 5 year
Secondary	Hemodynamic performance of the Freedom SOLO stentless valve: cardiac output (CO) Clinically significant improvement in overall patient condition.	Improvement of Cardiac Output	up to 5 year
Secondary	Hemodynamic performance of the Freedom SOLO stentless valve: cardiac index (CI) Clinically significant improvement in overall patient condition.	Improvement of Cardiac Index	up to 5 year
Secondary	Hemodynamic performance of the Freedom SOLO stentless valve: regurgitation Clinically significant improvement in overall patient condition.	Evaluation of regurgitation, location and severity	up to 5 year
Secondary	Preoperative and postoperative NYHA functional classifications	NYHA functional classification data is presented as the number and percentage of patients in each functional class.	Preoperatively, after the procedure (1 week), 3-6 months, 12 months and annually thereafter