Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000168550
Ethics application status
Approved
Date submitted
6/03/2006
Date registered
11/05/2006
Date last updated
11/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
PreFER MVP For Elective Replacement
Scientific title
PreFER MVP For Elective Replacement: Previously paced patients, coming in For Elective Replacement, using MVP (Managed Ventricular Pacing): to demonstrate the benefit of MVP in pacemaker and implantable carvioverter defibrillator (ICD) patients with a history of right ventricular pacing. The MVP function reduces unnecessary right ventricular pacing which has been shown to induce heart failure. Total mortality and heart failure hospitalization will be evaluated.
Secondary ID [1] 259 0
ClinicalTrials.gov: NCT00293241
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients with a history of RV pacing 1141 0
Condition category
Condition code
Cardiovascular 1221 1221 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Replacement of pacemaker or ICD with a new device featuring MVP. Results after a follow-up period of 2 years with MVP "ON" vs MVP "OFF" will be compared. At the end of the 2 years the doctor will determine which settings are preferred for the patient to be left on.
Intervention code [1] 927 0
None
Comparator / control treatment
MVP "OFF"
Control group
Placebo

Outcomes
Primary outcome [1] 1656 0
Demonstrate that MVP is superior to common clinical pacemaker and ICD programming in terms of freedom from all cause mortality or hospitalization for cardiovascular causes.
Timepoint [1] 1656 0
Measured at the end of 2 year follow-up period.
Secondary outcome [1] 2951 0
1. Occurence of Atrial Fibrillation/Atrial Tachycardia (AF/AT).
Timepoint [1] 2951 0
Timepoint measured: at the end of 2 year follow-up period.
Secondary outcome [2] 2952 0
2. Compare Left Ventricular Ejection Flow
Timepoint [2] 2952 0
Timepoint measured: at the end of 2 year follow-up period.

Eligibility
Key inclusion criteria
Patient with dual chamber pacemaker or ICD, paced for at least 2 years, who are due for a replacement of their device, male or female, who have signed the consent form or have a legal guardian willing to sign the consent form.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with cardiac resynchronization therapy indications, or permanent atrial fibrillation, or permanent atrioventricular block.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by internet
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified by Ejection Fraction and pacemaker vs ICD. Randomization is performed centrally using Trial XS remote data entry system.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
801
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1333 0
Commercial sector/Industry
Name [1] 1333 0
Medtronic Inc
Country [1] 1333 0
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Inc
Address
Country
United States of America
Secondary sponsor category [1] 1176 0
Commercial sector/Industry
Name [1] 1176 0
Medtronic Australiasia
Address [1] 1176 0
Country [1] 1176 0
Australia

Ethics approval
Ethics application status
Approved

Summary
Brief summary
This study protocol outlines the methodology and background behind the hypothesis that less ventricular pacing in a pacemaker and ICD is beneficial to the patients with a history of right ventricular pacing. This will be evaluated by comparing the rate of patient deaths and the need for hospitalizations when using less ventricular pacing vs. the normal, standard amount of ventricular pacing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35810 0
Address 35810 0
Country 35810 0
Phone 35810 0
Fax 35810 0
Email 35810 0
Contact person for public queries
Name 10116 0
Dr Henri Heynen
Address 10116 0
Medtronic Australasia
667 High Street
Kew East VIC 3102
Country 10116 0
Australia
Phone 10116 0
+61 3 88511007
Fax 10116 0
Email 10116 0
[email protected]
Contact person for scientific queries
Name 1044 0
Dr Henri Heynen
Address 1044 0
Medtronic Australasia
667 High Street
Kew East VIC 3102
Country 1044 0
Australia
Phone 1044 0
+61 3 88511007
Fax 1044 0
Email 1044 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.