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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Experimental group
Drugmedical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment).
Control group
Drugpatients of this group have no therapeutic or no treatment modification such as drug therapy
Treatment groups
Trial outcomes
Primary outcomes
occurence of Left ventricular dysfunction (PVC-iCMP)
The primary endpoint will be the development of left ventricular 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).
Secondary outcomes
Rate of Death
Death from any cause
Rate of Cardiovascular Death
measure of safety endpoint: Death cause of death
Rate of Hospitalization for an adverse event
occurence of adverse events (AE) and serious adverse events (SAE) within follow-up that may be linked or not to anti-arrhythmic drugs (AAD) or ablation procedure
Percentage of patients with a PVC burden <10%
measure of efficacy endpoints: PVC burden will be measured the second year following randomization
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: