Contact information
Type
Scientific
Primary contact
Mr Malcolm Dalrymple-Hay
ORCID ID
Contact details
Department of Cardiothoracic Surgery
Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom
+44 1392 262175
malcolm@dalrymple-hay.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
V10603
Study information
Scientific title
Mitroflow® vs Perimount® international clinical evaluation
Acronym
FLORENCE
Study hypothesis
Comparison of haemodynamic data (mitroflow® vs perimount® valves)
Ethics approval
To be submitted as of 23 November 2007
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Aortic stenosis
Intervention
Aortic valve replacement (Mitroflow® vs Perimount® valves)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The following haemodynamic data will be assessed at one and six months post implantation:
1. Effective orifice area
2. Mean pressure gradient
3. Peak pressure gradient
4. Degree LV remodelling
Secondary outcome measures
Morbidity and mortality. Duration of follow-up: Six months post implantation
Overall trial start date
01/01/2008
Overall trial end date
30/06/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing Aortic Valve Replacement (AVR) with annulus less than 25 cm
Participant type
Patient
Age group
Not Specified
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Poor left ventricular function
2. Redo-aortic valve replacement
3. Other associated disorders
4. Aged greater than 70 years
Recruitment start date
01/01/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Belgium, Italy, Switzerland, United Kingdom
Trial participating centre
Department of Cardiothoracic Surgery
Plymouth
PL6 8DH
United Kingdom
Sponsor information
Organisation
Sorin Biomedica Cardio S.R.L (Italy)
Sponsor details
Via Crescentino sn
Sallugia (VC)
13040
Italy
+39 75 5784281
direzione.medica@sorin.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Sorin Biomedica Cardio S.R.L (Italy)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary