Mitroflow® vs Perimount® international clinical evaluation
| ISRCTN | ISRCTN95484395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95484395 |
| Secondary identifying numbers | V10603 |
- Submission date
- 23/11/2007
- Registration date
- 02/01/2008
- Last edited
- 09/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Malcolm Dalrymple-Hay
Scientific
Scientific
Department of Cardiothoracic Surgery
Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 1392 262175 |
|---|---|
| malcolm@dalrymple-hay.com |
Study information
| Study design | Prospective randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Mitroflow® vs Perimount® international clinical evaluation |
| Study acronym | FLORENCE |
| Study objectives | Comparison of haemodynamic data (mitroflow® vs perimount® valves) |
| Ethics approval(s) | To be submitted as of 23 November 2007 |
| Health condition(s) or problem(s) studied | Aortic stenosis |
| Intervention | Aortic valve replacement (Mitroflow® vs Perimount® valves) |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/01/2008 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 150 |
| Key inclusion criteria | Patients undergoing Aortic Valve Replacement (AVR) with annulus less than 25 cm |
| Key exclusion criteria | 1. Poor left ventricular function 2. Redo-aortic valve replacement 3. Other associated disorders 4. Aged greater than 70 years |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 30/06/2009 |
Locations
Countries of recruitment
- Belgium
- England
- Italy
- Switzerland
- United Kingdom
Study participating centre
Department of Cardiothoracic Surgery
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Sponsor information
Sorin Biomedica Cardio S.R.L (Italy)
Industry
Industry
Via Crescentino sn
Sallugia (VC)
13040
Italy
| Phone | +39 75 5784281 |
|---|---|
| direzione.medica@sorin.com | |
| Website | http://www.sorin.com/ |
"ROR" |
https://ror.org/01ys7qn31 |
Funders
Funder type
Industry
Sorin Biomedica Cardio S.R.L (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/05/2016: No publications found, verifying study status with principal investigator.
