CAMERA-MRI II trial: Catheter Ablation versus Medical Rate Control of Atrial Fibrillation with Systolic Heart Failure and Myocardial Fibrosis – an MRI Guided Multi-Centre Randomised Controlled Clinical Trial
Not Applicable
Completed
- Conditions
- atrial fibrillationheart failureCardiovascular - Other cardiovascular diseasesSurgery - Surgical techniques
- Registration Number
- ACTRN12620000502932
- Lead Sponsor
- Alfred Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
Patients aged 18 years or older with AF and HF (LVEF 45% or below on CMR) who have trialled and failed at least 1 anti-arrhythmic agent or experienced AF recurrence following electrical cardioversion (DCR)
Exclusion Criteria
-CMR contraindication (eGFR <35mL/min, MRI-incompatible device)
-Catheter ablation contraindications such as ASD closure, LAA thrombus, anticoagulation contraindication
-AF >5yrs (where sinus rhythm is unlikely to be achieved or maintained)
-LVEF > 45% (CMR)
-Valvular AF
-Specific reversible HF aetiology (uncontrolled thyroid disease, excessive alcohol, myocarditis)
Within 3 months of planned cardiac intervention (PCI/CABG/implantable cardiac device) or planned intervention within 12 months of study enrolment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in LV ejection fraction (EF) on echocardiography and cardiac MRI from baseline to 12 months in LGE-positive catheter ablation versus medical rate control group[ 1. LVEF at 12 months<br>2. Change in LVEF from baseline to 12 months in catheter ablation versus medical rate control groups];Comparison of change in LV systolic function on echocardiography and cardiac MRI from baseline to 12 months in LGE-positive catheter ablation versus LGE-negative catheter ablation group[ LV systolic function at 12 months.]
- Secondary Outcome Measures
Name Time Method