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

Department of Cardiothoracic Surgery
Plymouth Hospitals NHS Trust
Plymouth
PL6 8DH
United Kingdom

Phone +44 1392 262175
Email malcolm@dalrymple-hay.com

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMitroflow® vs Perimount® international clinical evaluation
Study acronymFLORENCE
Study objectivesComparison of haemodynamic data (mitroflow® vs perimount® valves)
Ethics approval(s)To be submitted as of 23 November 2007
Health condition(s) or problem(s) studiedAortic stenosis
InterventionAortic valve replacement (Mitroflow® vs Perimount® valves)
Intervention typeOther
Primary outcome measureThe 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 measuresMorbidity and mortality. Duration of follow-up: Six months post implantation
Overall study start date01/01/2008
Completion date30/06/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants150
Key inclusion criteriaPatients undergoing Aortic Valve Replacement (AVR) with annulus less than 25 cm
Key exclusion criteria1. Poor left ventricular function
2. Redo-aortic valve replacement
3. Other associated disorders
4. Aged greater than 70 years
Date of first enrolment01/01/2008
Date of final enrolment30/06/2009

Locations

Countries of recruitment

  • Belgium
  • England
  • Italy
  • Switzerland
  • United Kingdom

Study participating centre

Department of Cardiothoracic Surgery
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Sorin Biomedica Cardio S.R.L (Italy)
Industry

Via Crescentino sn
Sallugia (VC)
13040
Italy

Phone +39 75 5784281
Email direzione.medica@sorin.com
Website http://www.sorin.com/
ROR logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

09/05/2016: No publications found, verifying study status with principal investigator.