Mitroflow® vs Perimount® international clinical evaluation
| ISRCTN | ISRCTN95484395 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95484395 |
| Protocol serial number | V10603 |
| Sponsor | Sorin Biomedica Cardio S.R.L (Italy) |
| Funder | Sorin Biomedica Cardio S.R.L (Italy) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
The following haemodynamic data will be assessed at one and six months post implantation: |
| Key secondary outcome measure(s) |
Morbidity and mortality. Duration of follow-up: Six months post implantation |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
- Belgium
- Italy
- Switzerland
Study participating centre
Department of Cardiothoracic Surgery
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
09/05/2016: No publications found, verifying study status with principal investigator.
