Status:
COMPLETED
Cardiac Resynchronisation Therapy and AV Nodal Ablation Trial in Atrial Fibrillation Patients (CAAN-AF)
Lead Sponsor:
University of Adelaide
Collaborating Sponsors:
Medtronic
Abbott Medical Devices
Conditions:
Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Cardiac resynchronization therapy (CRT) is a treatment for heart failure in patients who also suffer from ventricular dyssynchrony, a form of uncoordinated contraction of the ventricle (lower pumping ...
Detailed Description
Background: Cardiac Resynchronization Therapy (CRT) is an established treatment in heart failure (HF) patients with ventricular dyssynchrony who remain in sinus rhythm. Available clinical data has sho...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Persistent (≥ 1 month) or permanent atrial fibrillation. Persistent AF will be where obtaining and maintaining sinus rhythm is deemed either not worthwhile, or to be ineffective in the long term, or where both the patient and physician accept the presence of AF, where rhythm control intervention is, by definition no longer pursued. Permanent AF is defined as atrial fibrillation where sinus rhythm cannot be restored.
- NYHA class II , III or ambulatory class IV heart failure
- Left Ventricular Ejection Fraction (LVEF) ≤ 35% by objective criteria such as echocardiography, or cardiac MRI
- QRS duration on 12-lead ECG ≥ 120ms
- Able and willing to comply with all pre-, post- and follow-up testing and requirements.
Exclusion
- age \< 18 years
- pregnancy
- previous AV nodal ablation
- Second or third degree AV block
- Inability to provide informed consent
- life expectancy less than 24 months due to co-morbid illness other than heart failure erg cancer, end-stage renal disease, liver failure
- Paroxysmal Atrial Fibrillation that self terminates within 7 days
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2020
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT01522898
Start Date
March 1 2013
End Date
August 31 2020
Last Update
November 13 2020
Active Locations (33)
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1
Canberra Hospital
Canberra, Australian Capital Territory, Australia, 2605
2
Concord Hospital
Concord, New South Wales, Australia
3
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
4
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031