Atrial fibrillation (AF) is an irregular heartbeat that can cause symptoms of skipped beats, shortness of breath, stroke, or in some cases fluid in the lungs or legs. Treating AF is mostly to do with slowing the heart rate down so that the heart can get a chance to regain some energy. In some cases, slowing the heart rate is not easy to achieve as some patients find it difficult to tolerate medications and suffer side effects from these treatments. In these instances, there might be a possibility to permanently control the heart rate by implanting a pacemaker in the heart and intentionally damaging a regulatory region of the heart called the atrioventricular (AV) node. Damaging the AV node by a procedure called ablation results in the AF not being able to influence the bottom chambers (the ventricles) resulting in a slow rhythm. Therefore, if a pacemaker is implanted then the heart rate can be completely regulated by the pacemaker. A complex pacemaker that stimulates both the right and left ventricles simultaneously (BiVP) has been used for the last decade prior to AV node ablation. More recently, a technique has been designed to reduce the number of leads in the heart, reduce procedure time and have a similar effect on the heart called Conduction System Pacing (CSP). There is not enough existing evidence to show that a pace and ablate strategy is superior to optimal medical therapy. We intend to compare the efficacy of CSP with AV node ablation to optimal medical therapy for treating AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
600
Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA)
Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis
Victoria Cardiac Arrhythmia Trials
Victoria, British Columbia, Canada
NOT_YET_RECRUITINGNova Scotia Health Authority
Halifax, Nova Scotia, Canada
RECRUITINGHamilton Health Sciences Corporation
Hamilton, Ontario, Canada
RECRUITINGWaterloo Wellington Cardiovascular Research Institute
Kitchener, Ontario, Canada
RECRUITINGLondon Health Sciences Centre - University Hospital
London, Ontario, Canada
RECRUITINGSouthlake Regional Health Centre
Newmarket, Ontario, Canada
RECRUITINGOttawa Heart Institute Research Corporation
Ottawa, Ontario, Canada
RECRUITINGSunnybrook Health Sciences Centre
Toronto, Ontario, Canada
NOT_YET_RECRUITINGCentre Hospitalier de L'Université de Montréal (CHUM)
Montreal, Quebec, Canada
RECRUITINGMontreal Heart Institute
Montreal, Quebec, Canada
RECRUITING...and 2 more locations
Winratio
Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL.
Time frame: 12 months
All-cause mortality
Mortality from any cause within the 12 month of follow up period
Time frame: 12 months
Cardiovascular mortality
Mortality attributed to cardiovascular causes within 12 month follow up period
Time frame: 12 months
Number of heart failure events
Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay
Time frame: 12 months
All-cause hospitalization
ER admission or overnight stay
Time frame: 12 months
Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ)
Change in Kansas HF score from baseline. KCCQ is a 23-item self-administered questionnaire that measures the participant's perception of their health status, including their HF symptoms, impact on physical and social function and how their HF impacts the quality of life (QoL). KCCQ quantifies 7 domains: physical limitations (6 items), symptom stability (1 item), symptom frequency (4 items), symptom burden (3 items), self-efficacy (2 items), QoL (3 items) and social limitations (4 items). Scores were generated for each domain and scaled from 0 to 100, with 0 denoting the worst and 100 the best possible status.
Time frame: 6 months
Exercise
Change in 6 minute walk distance from baseline
Time frame: 6 months
Biochemical marker
Change in NTproBNP from baseline
Time frame: 6 months
Cognitive assessment
Change in cognitive assessment scores from baseline
Time frame: 12 months
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