Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000267358
Ethics application status
Approved
Date submitted
29/11/2007
Date registered
28/05/2008
Date last updated
24/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cardiac Resynchronization Therapy Based Heart Failure Monitoring Study
Scientific title
A nonrandomised trial on the safety and efficacy of performing intra-thoracic and intra-cardiac measurements, and realtime comparison with left atrial pressures using cardiac resynchronisation therapy in patients with heart failure.
Secondary ID [1] 497 0
CRT based heart failure monitoring study
Ethics Ref:URB/07/10/052
Secondary ID [2] 283113 0
nil known
Universal Trial Number (UTN)
Trial acronym
zLAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 2571 0
Condition category
Condition code
Cardiovascular 2680 2680 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients requiring the insertion of a Bi-ventricular pacemaker/defibrillator, for treatment of ventricular dyssynchrony and heart failure, will be offered the oppurtunity to participate in this trial. The sponsor will provide the PROMOTE device Model 3213, or later automatic internal cardiac defibrillator devices with similar functions. A HeartPOD (Left Atrial Pressure monitoring device) will be implanted at the same time. Research of the new features of the PROMOTE device to capture intra-thoracic and intra-cardiac electrical impedance measurements and left atrial pressures will be done. The completion of the trial will
be when the 12th participant has had one year of follow-up.
Intervention code [1] 2306 0
Treatment: Devices
Comparator / control treatment
Uncontrolled. Validity of left atrial pressure (LAP) measurements will be checked at Right Heart Catheterisations.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3583 0
Safety and efficacy of performing intra-thoracic and intra-cardiac measurements, and left atrial pressures.
Timepoint [1] 3583 0
Months 1-3 : Clinical Observation period where therapy is managed by physician based on clinical criteria.
Secondary outcome [1] 5999 0
Therapy managed by patient per "DynamicRX" based on twice daily left atrial pressure readings.
Timepoint [1] 5999 0
Months 4-6 : DynamicRX period
Secondary outcome [2] 6000 0
Therapy managed by physician based on clinical criteria and left atrial pressure
Timepoint [2] 6000 0
Months 4-6 : Titration period

Eligibility
Key inclusion criteria
Age>18 and <=85;an approved indication for cardiac resynchronization therapy via pacemaker(CRT-P) or cardiac resynchronization therapy via defibrillator(CRT-D);may be a Homeostasis 1 trial participant;able and willing to participate as per the trial protocol.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intractable Heart Failure or listed for cardiac transplantation; Acute Myocardial Infarction or Acute Coronary Syndrome; Recent surgery or (Percutaneous Coronary Intervention(PCI);Cerebrovascular Accident (CVA);Transient Ischaemic Attack(TIA);Pulmonary Embolus (PE);Deep Vein Thrombosis(DVT).

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)
Potential participants are consented. All participants will receive a defibrillator and a study device (left atrial pressure measurement device)
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
Phase
Phase 2 / Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2008
Actual
30/01/2008
Date of last participant enrolment
Anticipated
Actual
22/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 694 0
New Zealand
State/province [1] 694 0

Funding & Sponsors
Funding source category [1] 2841 0
Commercial sector/Industry
Name [1] 2841 0
St Jude Medical
Country [1] 2841 0
United States of America
Funding source category [2] 2842 0
Commercial sector/Industry
Name [2] 2842 0
St Jude Medical
Country [2] 2842 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
St Jude Medical
Address
15900 Valley View Court
Sylmar, CA 91342
Country
United States of America
Secondary sponsor category [1] 2563 0
Hospital
Name [1] 2563 0
Christchurch Hospital
Address [1] 2563 0
Riccarton Ave,
Christchurch
Country [1] 2563 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4788 0
Upper South B Regional Ethics Committee
Ethics committee address [1] 4788 0
Ethics committee country [1] 4788 0
New Zealand
Date submitted for ethics approval [1] 4788 0
08/10/2007
Approval date [1] 4788 0
12/11/2007
Ethics approval number [1] 4788 0
URB/07/10/052

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

Contacts
Principal investigator
Name 28204 0
A/Prof Richard Troughton
Address 28204 0
Cardiology Department
Christchurch Hospital
Private Bag 4710
Christchurch 8140
Country 28204 0
New Zealand
Phone 28204 0
+64 3 3640 640
Fax 28204 0
Email 28204 0
[email protected]
Contact person for public queries
Name 11361 0
Catherine Cruickshank
Address 11361 0
Cardiology Clinical Trials Unit
2nd Floor Parkside West
Christchurch Hospital
Country 11361 0
New Zealand
Phone 11361 0
+64 3 364 1096
Fax 11361 0
+64 3 378 6378
Email 11361 0
[email protected]
Contact person for scientific queries
Name 2289 0
Richard Troughton
Address 2289 0
Cardiology Department
2nd Floor Parkside West
Christchurch Hospital
Country 2289 0
New Zealand
Phone 2289 0
+64 3 364 1096
Fax 2289 0
+64 3 3641120
Email 2289 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.