Arrhythmia Atrial, Atrial Fibrillation, Heart Failure, Pacemaker
Conditions
Brief summary
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.
Interventions
DEVICEPace and Ablate
Conduction System Pacing (CSP) followed by AtrioVentricular Node Ablation (AVNA)
DRUGMedication
Optimization of heart failure therapies includes maximum tolerated doses of beta-blockers, aldosterone antagonists, ACE inhibitors, ARB, diuretics, ARNis
Sponsors
Habib Khan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with permanent AF/persistent AF (in AF) 2. Patients with NYHA Class II -IVa HF symptoms 3. Guideline driven medical therapy (GDMT) for HF for at least 3 months: * for those \< 75 years of age with an NT-proBNP of ≥ 600 ng/L * for those ≥ 75 years of age with an NT-proBNP ≥ 900 ng/L, or ≥ 600 ng/L if the patient has had a HF hospitalization within 1 year
Exclusion criteria
1. In hospital patients needing intensive care or intravenous inotropic agent in the last 4 days 2. Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year 3. Acute coronary syndrome \<4 weeks or coronary revascularization \<3months 4. Unable or unwilling to provide informed consent 5. Uncorrected primary valvular disease or prosthetic tricuspid valve 6. Restrictive, hypertrophic, or irreversible form of cardiomyopathy 7. Severe pulmonary diseases requiring oxygenation 8. Patients with a known history of WHO Class I pulmonary hypertension (PH) which includes PH associated with CVD, collagen vascular disease, congenital shunts, cirrhosis and portal hypertension, HIV, hemoglobinopathies, schistosomiasis or drug-associated PH as well as those with high suspicion of irreversible pulmonary hypertension 9. Patients enrolled in competitive clinical trials that will affect the objectives of this study 10. Existing CRT/BiVP 11. Patients who are pregnant 12. Guideline indication for CRT 13. More than 20% pacing with an existing pacemaker 14. Severe mobility limitations (ex. wheelchair bound and severe neurological conditions that limit mobility)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Winratio | 12 months | Reduction in the hierarchical composite outcomes of all-cause mortality and HF events frequency, improvement in NT-proBNP and improvement in QOL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 12 months | Mortality from any cause within the 12 month of follow up period |
| Cardiovascular mortality | 12 months | Mortality attributed to cardiovascular causes within 12 month follow up period |
| Number of heart failure events | 12 months | Heart failure related presentations to health care facilities necessitating intravenous diuretics or overnight stay |
| All-cause hospitalization | 12 months | ER admission or overnight stay |
| Quality of Life -Kansas City Cardiomyopathy Questionairre (KCCQ) | 6 months | 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. |
| Exercise | 6 months | Change in 6 minute walk distance from baseline |
| Biochemical marker | 6 months | Change in NTproBNP from baseline |
| Cognitive assessment | 12 months | Change in cognitive assessment scores from baseline |
Countries
Canada
Contacts
CONTACTHabib R Khan, MBBS, PhD
CONTACTKelli Tyndall
Outcome results
None listed