Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000340235
Ethics application status
Approved
Date submitted
4/02/2009
Date registered
25/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effects of coronary sinus based left atrial pacing on systemic hemodynamics in cardiac resynchronization therapy patients
Scientific title
Acute evaluation of effects of coronary sinus based left atrial pacing on systemic hemodynamics in cardiac resynchronization therapy patients
Secondary ID [1] 252120 0
CSLA
Universal Trial Number (UTN)
Trial acronym
CSLA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients requiring Cardiac Resynchronization Therapy 4266 0
Condition category
Condition code
Cardiovascular 4492 4492 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Left atrial pacing using a left atrial lead and electrophyisiology heart catheter stimulation for 30 seconds. This will be compared to the hemodynamic effects of traditional right atrial (RA)pacing using the implanted RA lead. Several pacing interventions (using a combination of right atrial and left atrial pacing combinations) and will be performed using a dedicated 4-channel pacing system. For each pacing intervention, the optimal timing setting will be determined as calculated by a real-time cardiac hemodynamic monitoring system. Each pacing intervention will be evaluated based on the resulting hemodynamic response. The entire pacing intervention will take 30 minutes and is administered only once in an acute setting.
Intervention code [1] 3992 0
Treatment: Devices
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5374 0
Hemodynamic measurements (changes in cardiac output) with coronary sinus (CS) based single and multisite left atrial (LA) pacing configurations
Timepoint [1] 5374 0
hemodynamic changes will be evaluated 30 seconds after pacing stimulation
Secondary outcome [1] 9037 0
systemic hemodynamics (cardiac output) of cardiac resynchronization therapy (CRT) employing bi-atrial pacing including both coronary sinus based left atrial pacing combined with right atrial based pacing
Timepoint [1] 9037 0
hemodynamic changes will be evaluated 30 seconds after pacing stimulation

Eligibility
Key inclusion criteria
undergoing cardiac resynchronization therapy (CRT) implantation
able to consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
no persistant or permanent atrial fibrillation (AF)
no recent myocardial infarction (MI) or Cardiac surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Control is right atrial pacing measurement for each patient. Pacing configuration order of testing will be randomized.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 1556 0
Canada
State/province [1] 1556 0
ON

Funding & Sponsors
Funding source category [1] 4448 0
Commercial sector/Industry
Name [1] 4448 0
St Jude Medical
Country [1] 4448 0
Canada
Funding source category [2] 4449 0
Commercial sector/Industry
Name [2] 4449 0
St Jude Medical
Country [2] 4449 0
Canada
Primary sponsor type
Commercial sector/Industry
Name
St Jude Medical
Address
2100 Derry Rd, Suite 400, Mississauga, ON, L5N 0B3
Country
Canada
Secondary sponsor category [1] 4008 0
None
Name [1] 4008 0
Address [1] 4008 0
Country [1] 4008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6502 0
Southlake Regional Health Center Research Ethics Board (REB)
Ethics committee address [1] 6502 0
Ethics committee country [1] 6502 0
Canada
Date submitted for ethics approval [1] 6502 0
Approval date [1] 6502 0
15/12/2008
Ethics approval number [1] 6502 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29246 0
Address 29246 0
Country 29246 0
Phone 29246 0
Fax 29246 0
Email 29246 0
Contact person for public queries
Name 12493 0
Linnea Aasen-Johnston
Address 12493 0
2100 Derry Rd, Suite 400, Mississauga, ON, L5N 0B3
Country 12493 0
Canada
Phone 12493 0
+1 905-286-4009
Fax 12493 0
Email 12493 0
[email protected]
Contact person for scientific queries
Name 3421 0
Mike Benser
Address 3421 0
15900 Valley View Court, Sylmar, CA, 91342-3577
Country 3421 0
United States of America
Phone 3421 0
+1 818-493-2345
Fax 3421 0
Email 3421 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.