Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000479404
Ethics application status
Approved
Date submitted
3/09/2007
Date registered
21/09/2007
Date last updated
29/06/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The protection of left ventricular function during right ventricular pacing.
Scientific title
PROTECT-PACE study: To assess the protection of left ventricular function during right ventricular pacing in patients diagnosed with complete heart block.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients diagnosed with high-grade A-V block requiring more than 90% ventricular pacing. 2323 0
Condition category
Condition code
Cardiovascular 2424 2424 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Implant of pacemaker and lead system. Results after a follow-up period of 24 months will be compared between right ventricular apex (RVA) vs right ventricular high septum (RVHS) lead placement. At the end of the study the treatment continues.

Right ventricular apex: Area at the base of the right ventricle in the heart.
Right ventricular high septum: Area near the top of the right ventricle closer to the middle of the heart.
Intervention code [1] 2041 0
Treatment: Devices
Comparator / control treatment
Right ventricular apex lead placement. At the end of the study the treatment continues.
Control group
Active

Outcomes
Primary outcome [1] 3323 0
To evaluate if RVHS pacing results in significantly improved left ventricular function (as measured by left ventricular ejection fraction) when compared to RVA pacing.
Timepoint [1] 3323 0
Measured after 24 months of pacing.
Secondary outcome [1] 5534 0
To evaluate if RVA pacing causes greater degree of left ventricular mechanical dyssynchrony compard to RVHS pacing.
Timepoint [1] 5534 0
At end of 24 month period.

Eligibility
Key inclusion criteria
Patients diagnosed with high-grade A-V block scheduled to undergo pacemaker implantation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient with intermittent AV block or scheduled for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy.

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 sealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomisation
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
Recruiting
Date of first participant enrolment
Anticipated
1/08/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
238
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 587 0
United Kingdom
State/province [1] 587 0
Country [2] 588 0
New Zealand
State/province [2] 588 0

Funding & Sponsors
Funding source category [1] 2583 0
Commercial sector/Industry
Name [1] 2583 0
Medtronic Inc
Country [1] 2583 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Medtronic Australasia
Address
677 High St,
Kew East, Vic, 3102
Country
Australia
Secondary sponsor category [1] 2335 0
Commercial sector/Industry
Name [1] 2335 0
Medtronic UK Ltd.
Address [1] 2335 0
Sherbourne House
Croxley Business Centre,
Watford, WD18 8WW, UK
Country [1] 2335 0
United Kingdom

Ethics approval
Ethics application status
Approved

Summary
Brief summary
For many years the standard approach to lead placement has been the right ventricular apex (RVA). However, early evidence suggests that right ventricular high septum (RVHS) pacing may be more beneficial compared to RVA pacing. Patients with complete heart block requiring more than 90% ventricular pacing will be randomised into two groups; RVA vs RVHS pacing. The two pacing modalities will be compared to assess left ventricular function as measured by the left ventricular ejection fraction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28024 0
Address 28024 0
Country 28024 0
Phone 28024 0
Fax 28024 0
Email 28024 0
Contact person for public queries
Name 11181 0
Dr. Cara Weisbrod
Address 11181 0
Medtronic Australasia
Suite 6, 667 High St, Kew East, Vic, 3102
Country 11181 0
Australia
Phone 11181 0
+61 3 8851 1016
Fax 11181 0
Email 11181 0
[email protected]
Contact person for scientific queries
Name 2109 0
Dr. Cara Weisbrod
Address 2109 0
Medtronic Australasia
Suite 6, 667 High St, Kew East, Vic, 3102
Country 2109 0
Australia
Phone 2109 0
+61 3 8851 1016
Fax 2109 0
Email 2109 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.