Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000051044
Ethics application status
Approved
Date submitted
15/01/2010
Date registered
18/01/2010
Date last updated
15/12/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of the benefits of frequent optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibrillator Device (CRT-D)
Scientific title
A prospective, randomized, double-blinded, multicentre study to evaluate the benefits of frequent Atrio Ventricular (AV/PV) and Inter-Ventricular (V-V) delay optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibribrillator (CRT-D) Device.
Secondary ID [1] 1288 0
NCT00418314: Clinicaltrials.gov
Universal Trial Number (UTN)
Trial acronym
FREEDOM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Life-threatening ventricular arrhythmias 256540 0
Condition category
Condition code
Cardiovascular 256713 256713 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is aimed at demonstrating that frequent AV/PV and V-V delay optimisation using QuickOpt in patients with Cardiac Resynchronisation Therapy Defibrillation devices results in improved clinical response over standard of care (i.e. empiric programming or one-time optimisation using any non-intracardiac electrogram optimisation methods). SJM has developed inter-ventricular (V-V) delay optimisation to synchronize the electrical activation of the conducted intrinsic and paced wavefronts between the pacing electrodes. The Atrio-ventricular (AV/PV) optimisation method characterises the inter-atrial conduction patterns in order to maximise preload and allow for proper timing of mitral valve closure. The intervention is observed for a period of 12 months, from which time the device will remain implanted.
Intervention code [1] 255817 0
Treatment: Devices
Comparator / control treatment
Empiric programming or optimisation as per sites standard of care for the duration of the study: for example EchoCardioGram (ECHO).
Control group
Active

Outcomes
Primary outcome [1] 257600 0
Heart Failure (HF) clinical composite score as defined by Packer: Proposal for a new clinical end point to evaluate the efficacy of drugs and devices in the treatment of chronic heart failure, Journal of Cardiac Failure 2001: 7, 2; 176-182.
Timepoint [1] 257600 0
Improvement at 12 months over baseline
Secondary outcome [1] 262871 0
All-cause cardiovascular and heart failure mortality: Any cause during the 12month follow up will be collected for all patietns within 2 weeks of the incident - Complete device interrogation, print device data and Adverse Event/hospitalisation Case Report Form (CRF) completion
Timepoint [1] 262871 0
Up to 12 months post implant
Secondary outcome [2] 262872 0
All-cause cardiovascular and heart failure hospitalisations: Any cause during the 12month follow up will be collected for all patietns within 2 weeks of the incident - Complete device interrogation, print device data and AE/hospitalisation CRF completed
Timepoint [2] 262872 0
Up to 12 months post implant.

Eligibility
Key inclusion criteria
- Patient meets current CRT-D indications and be implanted with a St. Jude Medical (SJM) CRT-D device with V-V timing and a copatible lead system.
- Patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath
-Patient has the ability to independantly comprehend and complete a Quality Of Life (QOL) questionnaire
- Patient is geographically stable and willing to coply with the required follow up schedule
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patient has an epicardial ventricular lead system
-patient has the ability to walk greater or equal to 450 meters in 6 meters
- Patient has limited intrinsic atrial activity (<40bpm)
- Patient has persistent or permanent Atrial Fibrillation (AF)
- Patient has a 2 or 3 degree heart block
- Patients life expectancy is less than a year
- Patient is less than 18yrs old
- Patient is pregnant
- Patient is on an Intravenous (IV) inotropic agent

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)
All patients must meet indications to be implanted with a SJM CRT-D device with V-V timing and compatible lead system. The CRT-D must be switched ON prior to performing any baseline measurements at enrollment. Patients must be enrolled withing two weeks post CRT-D implant.
Randomisation will be blocked by investigational sitet and stratified by the patients cardiomyopathy classification of ischemic or non-ischemic. In order to do so sealed opaque envelopes will be used for the randomisation process
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Neither the patient nor the physician/nursing staff performing the HF assessment will be aware of the randomisation assignement. Heart Failure Clinical composite Assessement CRF is completed by and signed by a blinded rater only. Randomisation will be done via stratification based upon the patients cardiomyopathy classification of: ischemic or on-ischemic.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/08/2007
Actual
23/10/2006
Date of last participant enrolment
Anticipated
3/10/2008
Actual
3/10/2008
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
1652
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment postcode(s) [1] 2392 0
2010
Recruitment postcode(s) [2] 2395 0
2076
Recruitment postcode(s) [3] 12463 0
3076 - Epping
Recruitment postcode(s) [4] 2393 0
4001
Recruitment postcode(s) [5] 2394 0
6909
Recruitment outside Australia
Country [1] 7425 0
United States of America
State/province [1] 7425 0
Country [2] 7426 0
Austria
State/province [2] 7426 0
Country [3] 7427 0
Belgium
State/province [3] 7427 0
Country [4] 7428 0
Canada
State/province [4] 7428 0
Country [5] 7429 0
China
State/province [5] 7429 0
Country [6] 7430 0
Denmark
State/province [6] 7430 0
Country [7] 7431 0
Finland
State/province [7] 7431 0
Country [8] 7432 0
France
State/province [8] 7432 0
Country [9] 7433 0
Germany
State/province [9] 7433 0
Country [10] 7434 0
Greece
State/province [10] 7434 0
Country [11] 7435 0
Ireland
State/province [11] 7435 0
Country [12] 7436 0
Israel
State/province [12] 7436 0
Country [13] 7437 0
Italy
State/province [13] 7437 0
Country [14] 7438 0
Spain
State/province [14] 7438 0
Country [15] 7439 0
Sweden
State/province [15] 7439 0
Country [16] 7440 0
Switzerland
State/province [16] 7440 0
Country [17] 7441 0
United Kingdom
State/province [17] 7441 0

Funding & Sponsors
Funding source category [1] 256311 0
Commercial sector/Industry
Name [1] 256311 0
St. Jude Medical
Country [1] 256311 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
St. Jude Medical
Address
St. Jude Medical World Headquarters
One Lellehei Plaza
St. Paul MN 55117
Country
United States of America
Secondary sponsor category [1] 251630 0
None
Name [1] 251630 0
Address [1] 251630 0
Country [1] 251630 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258394 0
St Vincents Hospital Human Research Ethics Committee
Ethics committee address [1] 258394 0
390 Victoria Rd
Darlinghurst NSW 2010
Ethics committee country [1] 258394 0
Australia
Date submitted for ethics approval [1] 258394 0
Approval date [1] 258394 0
Ethics approval number [1] 258394 0
H06/156
Ethics committee name [2] 258395 0
Uniting Care health Human Research Ethics Committee
Ethics committee address [2] 258395 0
PO Box 499
toowong QLD 4066
Ethics committee country [2] 258395 0
Australia
Date submitted for ethics approval [2] 258395 0
Approval date [2] 258395 0
26/04/2007
Ethics approval number [2] 258395 0
2007/16
Ethics committee name [3] 258396 0
The Northern Hospital Human Research Ethics Committee
Ethics committee address [3] 258396 0
185 Cooper St
Epping VIC 3076
Ethics committee country [3] 258396 0
Australia
Date submitted for ethics approval [3] 258396 0
Approval date [3] 258396 0
30/03/2007
Ethics approval number [3] 258396 0
10/07/2010
Ethics committee name [4] 258399 0
Hollywood Private Hopsital Human Research Ethics Committee
Ethics committee address [4] 258399 0
Monash Avenue
Nedlands WA 6909
Ethics committee country [4] 258399 0
Australia
Date submitted for ethics approval [4] 258399 0
Approval date [4] 258399 0
15/08/2007
Ethics approval number [4] 258399 0
HPA235

Summary
Brief summary
The purpose of this study is to prospectively evaluate the benefits of frequent AV/PV and V-V delay optimisation using QuickOpt in patients iwth CRT-D devices
Trial website
Trial related presentations / publications
NA
Public notes

Contacts
Principal investigator
Name 30701 0
Dr Dr Gras
Address 30701 0
Nouvelles Cliniques Nantaises
Country 30701 0
France
Phone 30701 0
+0033228255115
Fax 30701 0
Email 30701 0
dgras@ncn.fr
Contact person for public queries
Name 13948 0
Ms Lisa Guzzo
Address 13948 0
Clinical Projects Leader
Leonardo Da Vincillaan 11, Box F1
Zaventem 1935
Country 13948 0
Belgium
Phone 13948 0
+322 774 6856
Fax 13948 0
+322 774 6946
Email 13948 0
lguzzo@sjm.com
Contact person for scientific queries
Name 4876 0
Ms Lisa Guzzo
Address 4876 0
Clinical Projects Leader
Leonardo Da Vincilaan 11, Box F1
Zaventem 1935
Country 4876 0
Belgium
Phone 4876 0
+322 774 6856
Fax 4876 0
+322 774 6946
Email 4876 0
lguzzo@sjm.com

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
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