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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacological Therapy | Active Comparator | Patients randomized to pharmacology rate control will receive guideline-directed HF management across all ranges of LVEF, including appropriate rate control medications. ICD will be inserted in those patients who have LVEF ≤35% |
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| P&A-CSP | Experimental | Patients randomized to P&A-CSP will receive a CSP and ICD if LVEF ≤35% within 10 working days of randomization. Catheter AVNA will be performed within 4 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pace and Ablate | Device | Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Winratio | Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | Mortality from any cause within the 12 month of follow up period | 12 months |
| Cardiovascular mortality | Mortality attributed to cardiovascular causes within 12 month follow up period |
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Inclusion Criteria:
Patients with permanent AF/persistent AF (in AF)
Patients with NYHA Class II -IVa HF symptoms
Guideline driven medical therapy (GDMT) for HF for at least 3 months:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Habib R Khan, MBBS, PhD | Contact | 519-6633746 | habib.khan@lhsc.on.ca | |
| Kelli Tyndall | Contact | 519-685-8500 | 37232 | Kelli.Tyndall@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Victoria Cardiac Arrhythmia Trials | Recruiting | Victoria | British Columbia | Canada |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D013678 | Technology, Pharmaceutical |
| D008919 | Investigative Techniques |
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| Medication | Drug | Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis |
|
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| 12 months |
| Number of heart failure events | Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay | 12 months |
| All-cause hospitalization | ER admission or overnight stay | 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. | 6 months |
| Exercise | Change in 6 minute walk distance from baseline | 6 months |
| Biochemical marker | Change in NTproBNP from baseline | 6 months |
| Cognitive assessment | Change in cognitive assessment scores from baseline | 12 months |
| Nova Scotia Health Authority | Recruiting | Halifax | Nova Scotia | B3S0H6 | Canada |
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| Hamilton Health Sciences Corporation | Recruiting | Hamilton | Ontario | L8L2X2 | Canada |
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| Waterloo Wellington Cardiovascular Research Institute | Recruiting | Kitchener | Ontario | N2G1G3 | Canada |
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| London Health Sciences Centre - University Hospital | Recruiting | London | Ontario | N6A5A5 | Canada |
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| Southlake Regional Health Centre | Recruiting | Newmarket | Ontario | Canada |
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| Ottawa Heart Institute Research Corporation | Recruiting | Ottawa | Ontario | K1Y4W7 | Canada |
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| Sunnybrook Health Sciences Centre | Recruiting | Toronto | Ontario | Canada |
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| Centre Hospitalier de L'Université de Montréal (CHUM) | Recruiting | Montreal | Quebec | H2X0A9 | Canada |
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| Montreal Heart Institute | Recruiting | Montreal | Quebec | Canada |
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| Institut universitaire de cardiologie et de pneumologie Québec - Université Laval (IUCPQ-ULaval) | Recruiting | Québec | Quebec | G1V4G5 | Canada |
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| Hôpital Fleurimont | Recruiting | Sherbrooke | Quebec | J1H5N4 | Canada |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |