Clinical Investigation of the Freedom SOLO Stentless Heart Valve

Sponsor

LivaNova (Industry)

Overall Status

Completed

CT.gov ID

NCT00876525

Collaborator

(none)

700

Enrollment

Locations

Arm

102

Duration (Months)

36.8

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

700 participants

Allocation:

N/A

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 :

Mar 1, 2009

Actual Primary Completion Date :

Dec 1, 2013

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The complication and survival rates for the Freedom SOLO stentless valve. [Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion.]

Secondary Outcome Measures

Hemodynamic performance of the Freedom SOLO stentless valve. Clinically significant improvement in overall patient condition. [Preoperatively, at implant, early postoperative, late postoperative, 1 year, annually until study completion.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	Krankenhaus Hietzing	Wien	Austria	1030
2	Medical University Vienna	Wien	Austria	1090
3	St. Luc Hospital	Bruxelles	Belgium	1200
4	University Hospital Gent	Gent	Belgium	9000
5	Hôpital Pontchaillou - CHU	Rennes	France	35033
6	Hôpital Trousseau - CHRU	Tours	France	37000
7	Herz- und Gefäß-Klinik GmbH	Bad Neustadt	Germany	97616
8	Charité Hospital	Berlin	Germany	10117
9	Herzzentrum Dresden Universitätsklinik an der Technischen Universität Dresden	Dresden	Germany	01307
10	Universitätsklinikum Erlangen, Klinik für Herzchirurgie	Erlangen	Germany	91054
11	Ospedale del Cuore, Fondazione G. Monasterio	Massa	Italy	54100
12	Ospedale "S. Maria di Ca' Foncello"	Treviso	Italy	31100
13	Ospedale S. Maria Della Misericordia	Udine	Italy	33100
14	Academisch Medisch Centrum	Amsterdam	Netherlands	1100 DD
15	Catharina Hospital	Eindhoven	Netherlands	5623 EJ
16	Medisch Spectrum Twente, Thoraxcentrum	Enschede	Netherlands	7513 ER
17	University Hospital St. Radboud	Nÿmegen	Netherlands	6500 HB
18	Hospital S. João	Porto	Portugal	4200-319
19	Inselspital, University Hospital Berne	Bern	Switzerland	3010