About this trial
The main objective of the study is to demonstrate that prophylactic treatment of patients with asymptomatic frequent (\>10%) PVCs is superior to simple follow-up strategy with no therapy to prevent subsequent LV dysfunction at 24 months. The prophylactic treatment is based on drugs ± ablation (ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment since the initiation of the study).
The primary endpoint will be the development of LV dysfunction (PVC-iCMP) defined as a 15% relative LVEF decrease (and/or a LVEF \<50%) within 2 years following randomization, on cardiac magnetic resonance imaging (cMRI) (or transthoracic echocardiography (TTE) when not possible).
Eligibility criteria
Qualifiers
18 ≤ Age ≤ 85
PVC burden ≥ to 10% regardless of current or preexisting antiarrhythmic drug intake (for instance, a patient under betablocker therapy because of his PVCs or hypertension can be included)
Asymptomatic status
Normal (>or= 55%) LVEF. Patients with underlying cardiomyopathy can be included as long as LV function remains preserved.
Disqualifiers
Pregnant woman or Female of childbearing potential without effective method of birth control or nursing woman.
Patients that can't undergo MRI study
De novo requirement for antiarrhythmic drug prescription for another indication (e.g. atrial fibrillation…)
The physician already decided that the patient requires drug initiation or escalation;
Trial design
Treatments tested in this trial
- Experimental group
- Control group