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Trial registered on ANZCTR


Registration number
ACTRN12613000880741
Ethics application status
Approved
Date submitted
17/07/2013
Date registered
7/08/2013
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Date results information initially provided
11/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A multicentre randomized control study of atrial fibrillation in heart failure (CAMERA-MRI)
Scientific title
Catheter Ablation versus MEdical Rate control in Atrial fibrillation and heart failure – An MRI guided multi-centre randomised controlled trial – the CAMERA-MRI study.
Secondary ID [1] 282847 0
Nil known
Universal Trial Number (UTN)
Trial acronym
CAMERA-MRI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 289654 0
Heart Failure 289655 0
Condition category
Condition code
Cardiovascular 289972 289972 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 - Catheter Ablation
Catheter ablation of AF is a minimally invasive procedure (involving the use of specialized instruments through the groin to make a small burn in the area of the heart that is responsible for irregular heart rates) which can eliminate AF in many patients. However in patients with AF and HF, it is currently difficult to identify those in whom the AF is causing or significantly contributing to the HF. Such patients may benefit from catheter ablation. Patients with HF display a unique pattern of scarring in the heart muscle capable of being detected by magnetic resonance imaging (MRI). The amount of scarring in the heart muscle appears proportional to the degree of reversibility of HF. Thus in patients with AF and HF, we propose that MRI may help identify those patients whose HF is most likely to improve, or even completely reverse, following catheter ablation. In this way, catheter ablation may become a useful tool in the treatment of patients with AF and HF.
Catheter ablation will be guided using a 3D mapping system with integration of the left atriogram obtained at the time of MRI. Ablation is performed with an irrigated tip catheter to encircle the left and right sided pulmonary veins (PV) in pairs 1-2 cms from their ostia as defined by PV angiography and the 3D map. At the anterior aspect of the left PVs, ablation is performed along the ridge between the Left Atrial Appendage (LAA) and the PV ostia. The PVs are continuously assessed for electrical disconnection using the circular mapping catheter. If AF continues following PV electrical isolation further substrate modification is at the discretion of the operator and may include (i) linear ablation – a roof line joining the superior aspects of each wide encirclement ablation ring and an inferior LA line to achieve electrical isolation of the posterior LA wall or a mitral isthmus line and/or (ii) complex fractionated electrograms - left and right atria are mapped systematically for fractionated potentials which are then targeted for ablation. The procedure takes approximately 2-4 hours.
Intervention code [1] 287539 0
Treatment: Surgery
Comparator / control treatment
Arm 2 - Pharmacological rate control
Rate control involves using medications designed to make the heart rate slower by slowing electrical impulses flowing through the Atrio Ventricular node. These include beta blockers (Atenolol, Bisoprolol, Carvedilol, Metropolol, Propranolol, Sotolol) and the cardiacglycoside Digoxin. Individual participant dosage, frequency and duration will be prescribed by the Chief Investigator.
Control group
Active

Outcomes
Primary outcome [1] 290022 0
Recovery of Left Ventricular function assesed by improvement in Ejection Fraction determined by cardiac MRI and Echocardiography.
Timepoint [1] 290022 0
Assessed at 6 months.
Primary outcome [2] 290023 0
Restoration of sinus rhythm assessed by Loop Recorder Interrogation (Catheter Ablation Arm) Holter Monitoring and Electrocardiography (Rate Control Arm).
Timepoint [2] 290023 0
Loop Recorder assessed at 6 weeks, 3 and 6 months.
Holter Monitoring assessed at 3 and 6 months.
Secondary outcome [1] 303790 0
Improvement in Heart Failure symptoms as assessed by the 6 Minute Walk Test (6MWT) and Quality of Life as assesed by the individual participant using the SF36v2 Health Survey.
Timepoint [1] 303790 0
6MWT and SF36 assessed at 3 and 6 months.

Eligibility
Key inclusion criteria
Paroxysmal or persistent AF
LVEF < 45%
Dilated Cadriomyopathy
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non MRI safe Pacemaker, ICD or BiVentricular Device
Renal Impairment Cr > 200
Left atrial thrombus

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size calculation for the primary endpoint of LVEF assumes the mean EF of both groups (AF ablation and medical therapy) is 40+/-10% based on preliminary data. We will aim to detect minimum absolute difference in EF of 10% then 16 patients will be required in each group to provide a power of 0.8 at an alpha value of 0.05. Successful restoration of sinus rhythm with catheter ablation in this patient population is estimated at 80% requiring 20 patients in each group. Differences in proportions will compared by a chi-squared analysis or Fisher’s Exact Test. Comparisons between groups will be performed with either an unpaired Student’s T-Test or where a normal distribution could not be assumed the Mann Whitney U test.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
27/11/2013
Date of last participant enrolment
Anticipated
Actual
6/10/2016
Date of last data collection
Anticipated
Actual
8/05/2017
Sample size
Target
80
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 1324 0
The Alfred - Prahran
Recruitment hospital [2] 1325 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 1326 0
Melbourne Private Hospital - Parkville
Recruitment hospital [4] 8205 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 16264 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 287625 0
Government body
Name [1] 287625 0
NHMRC
Country [1] 287625 0
Australia
Primary sponsor type
Other
Name
Baker IDI Heart & Diabetes Institute
Address
75 Commercial Road,
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 286369 0
None
Name [1] 286369 0
None
Address [1] 286369 0
N/A
Country [1] 286369 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289596 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 289596 0
Alfred Hospital,
Commercial Road,
Prahran,
VIC 3004
Ethics committee country [1] 289596 0
Australia
Date submitted for ethics approval [1] 289596 0
22/07/2013
Approval date [1] 289596 0
03/09/2013
Ethics approval number [1] 289596 0
EC00315
Ethics committee name [2] 297830 0
Melbourne Health
Ethics committee address [2] 297830 0
Royal Melbourne Hospital
300 Gratten Street
Parkville, VIC, 3050
Ethics committee country [2] 297830 0
Australia
Date submitted for ethics approval [2] 297830 0
01/03/2015
Approval date [2] 297830 0
18/08/2015
Ethics approval number [2] 297830 0
HREC/14/MH/237
Ethics committee name [3] 297831 0
Monash Medical Centre
Ethics committee address [3] 297831 0
Monash Medical Centre
246 Clayton Road
Clayton, Victoria, 3168
Ethics committee country [3] 297831 0
Australia
Date submitted for ethics approval [3] 297831 0
01/02/2015
Approval date [3] 297831 0
30/04/2015
Ethics approval number [3] 297831 0
HRECREF:15120X

Summary
Brief summary
Heart failure (HF) is a common heart condition whereby the pumping capacity of the heart is significantly reduced. It is the end result of many conditions which weaken the heart muscle. Atrial fibrillation (AF) is a common electrical disturbance of the heart which results in rapid and irregular heart rates which may cause HF or significantly worsen pre-existing HF. Similarly, HF may cause AF which may then worsen the severity of HF. Catheter ablation of AF is a minimally invasive procedure (involving the use of specialized instruments through the groin to make a small burn in the area of the heart that is responsible for irregular heart rates) which can eliminate AF in many patients. However, in patients with AF and HF, it is currently difficult to identify those in whom the AF is causing or significantly contributing to the HF. Such patients may benefit from catheter ablation. Patients with HF display a unique pattern of scarring in the heart muscle capable of being detected by magnetic resonance imaging (MRI) (non-invasive scan of the heart). The amount of scarring in the heart muscle appears proportional to the degree of reversibility of HF. Thus in patients with AF and HF, we propose that MRI may help identify those patients whose HF is most likely to improve, or even completely reverse, following catheter ablation. In this way, catheter ablation may become a useful tool in the treatment of patients with AF and HF.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41498 0
A/Prof Peter Kistler
Address 41498 0
Head, Clinical Electrophysiology Research,
Applied cardiovascular Research,
Baker IDI Heart & Diabetes Institute,
75 Commercial Road,
Melbourne,
VIC 3004
Country 41498 0
Australia
Phone 41498 0
+613 8532 1427
Fax 41498 0
+613 90762461
Email 41498 0
[email protected]
Contact person for public queries
Name 41499 0
Peter Kistler
Address 41499 0
Head, Clinical Electrophysiology Research,
Applied cardiovascular Research,
Baker IDI Heart & Diabetes Institute,
75 Commercial Road,
Melbourne,
VIC 3004
Country 41499 0
Australia
Phone 41499 0
+613 8532 1427
Fax 41499 0
+613 90762461
Email 41499 0
[email protected]
Contact person for scientific queries
Name 41500 0
Peter Kistler
Address 41500 0
Head, Clinical Electrophysiology Research,
Applied cardiovascular Research,
Baker IDI Heart & Diabetes Institute,
75 Commercial Road,
Melbourne,
VIC 3004
Country 41500 0
Australia
Phone 41500 0
+613 8532 1427
Fax 41500 0
+613 90762461
Email 41500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Catheter Ablation Versus Medical Rate Control in A... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseCatheter Ablation Versus Medical Rate Control in Atrial Fibrillation and Systolic Dysfunction: The CAMERA-MRI Study.2017https://dx.doi.org/10.1016/j.jacc.2017.08.041
EmbaseCatheter Ablation Versus Medication in Atrial Fibrillation and Systolic Dysfunction: Late Outcomes of CAMERA-MRI Study.2020https://dx.doi.org/10.1016/j.jacep.2020.08.019
EmbaseThe need to refine selection criteria for catheter ablation in heart failure patients with atrial fibrillation.2022https://dx.doi.org/10.1093/europace/euab239
N.B. These documents automatically identified may not have been verified by the study sponsor.