Condition category
Circulatory System
Date applied
23/11/2007
Date assigned
02/01/2008
Last edited
09/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.sorin.com/

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

Publication citations

Additional files

Editorial Notes

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