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A multicentre randomized control study of atrial fibrillation in heart failure (CAMERA-MRI)

Catheter Ablation versus MEdical Rate control in Atrial fibrillation and heart failure – An MRI guided multi-centre randomised controlled trial – the CAMERA-MRI study.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000880741
Acronym
CAMERA-MRI
Enrollment
66
Registered
2013-08-07
Start date
2013-11-27
Completion date
2016-10-06
Last updated
2020-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 disp

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.

Sponsors

Baker IDI Heart & Diabetes Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Paroxysmal or persistent AF LVEF < 45% Dilated Cadriomyopathy

Exclusion criteria

Non MRI safe Pacemaker, ICD or BiVentricular Device Renal Impairment Cr > 200 Left atrial thrombus

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 9, 2026