Objective
The primary objective of the trial is to evaluate the optimal strategy to manage patients with permanent AF and heart failure — comparing pharmacological therapies and a Pace-and-Ablate with conduction system pacing (P&A-CSP) strategy — to reduce mortality and heart failure hospitalizations, reduce NT-proBNP, and improve quality of life. Secondary objectives evaluate biochemical changes such as NT-proBNP, 6-minute walk distance, and cardiac function on echocardiogram.
Background
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) by capturing the natural specialized cells that conduct electricity. 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 Outcomes
Primary
- Reduction in the hierarchical composite of all-cause mortality and HF event frequency, improvement in NT-proBNP, and improvement in quality of life
Secondary
- All-cause mortality
- Cardiovascular mortality
- Number of worsening HF events (worsening HF signs requiring intravenous HF therapy, ultrafiltration at a healthcare facility, or hospitalization for HF ≥ 24 hours)
- All-cause hospitalization
- Change in Kansas City Cardiomyopathy Questionnaire overall summary score (KCCQ-OSS) at 6 months from baseline
- 6-minute walk distance change at 6 months from baseline
- NT-proBNP change at 6 months from baseline
- Changes in cognitive function (memory, reasoning, verbal ability and concentration)
Eligibility Criteria
The criteria below are a summary. Your study doctor will confirm whether this study is right for you.
Inclusion Criteria
- Patients with permanent AF / persistent AF
- Patients with NYHA Class II–IVa HF symptoms
- Guideline-driven medical therapy (GDMT) for HF for at least 3 months:
- < 75 years of age with an NT-proBNP ≥ 600 ng/L
- ≥ 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
- In-hospital patients needing intensive care or intravenous inotropic agent in the last 4 days
- Patients with a life expectancy of ≤ 1 year from non-cardiac cause or anticipating a transplant within 1 year
- Acute coronary syndrome < 4 weeks or coronary revascularization < 3 months
- Unable or unwilling to provide informed consent
- Uncorrected primary valvular disease or prosthetic tricuspid valve
- Restrictive, hypertrophic, or irreversible form of cardiomyopathy
- Severe pulmonary diseases requiring oxygenation
- Known history of WHO Class I pulmonary hypertension or high suspicion of irreversible pulmonary hypertension
- Patients enrolled in competing clinical trials that would affect the objectives of this study
- Existing CRT / BiVP
- Patients who are pregnant
- Guideline indication for CRT
- More than 20% pacing with an existing pacemaker
- Severe mobility limitations
About taking part
If you would like to learn more about taking part in this study, please contact our research team using the details on this page. We can walk you through what participation involves and answer any questions.