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NOT YET RECRUITING
NCT05784051
PHASE4

Prophylactic Frequent Premature Ventricular complexeS sUPPression on Left ventriculaR Function impairmEnt in aSymptomatic patientS

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

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).

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

298

Start Date

2023-10-01

Completion Date

2027-06-01

Last Updated

2023-09-06

Healthy Volunteers

No

Interventions

DRUG

Experimental group

medical treatment including drug administration ± catheter ablation (Ablation can be performed if the PVC burden remain \>10% after 2 lines of AAD treatment).

DRUG

Control group

patients of this group have no therapeutic or no treatment modification such as drug therapy