Clinical Trials Directory

Trials / Completed

CompletedNCT03845010

Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
22 (actual)
Sponsor
Maatschap Cardiologie Zwolle · Academic / Other
Sex
All
Age
76 Years
Healthy volunteers
Not accepted

Summary

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.

Detailed description

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.

Conditions

Interventions

TypeNameDescription
DRUGSotalolPatients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
DRUGFlecainide and verapamilPatients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day
PROCEDURECatheter ablationPatients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine

Timeline

Start date
2019-02-12
Primary completion
2023-01-17
Completion
2023-01-17
First posted
2019-02-19
Last updated
2023-06-28

Locations

1 site across 1 country: Netherlands

Source: ClinicalTrials.gov record NCT03845010. Inclusion in this directory is not an endorsement.