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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
Patients 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
Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
Isala hospital
Zwolle, Netherlands
Successful therapy
Number of patients reaching succesfull therapy defined as \>80% reduction of of VPB/VT burden after 3 months
Time frame: After 3 months
VPB/VT burden
Time frame: 3, 6, 12 months after intervention
Change in VPB/VT burden
Measurement in different subgroups e.g.: males, pre and post-menopausal women
Time frame: Before the intervention (baseline) and 3, 6, 12 months after intervention
The impact in terms of total Quality of Life
Use of the University of Toronto AF severity scale (AFSS) questionnaire to measure Quality of Life. The total score range is 0-35. Seven questions in total with a maximum score of 5 points per question.
Time frame: 3, 6, 12 months after intervention compared to baseline (before intervention)
Association between number of VPB/hour and heart rate (HR)/hour during 24-hours Holter- monitoring
A scatterplot will be made in order to depict the association between the number of VBP/hour and heart rate (HR)/hour during 24-hour Holter-monitoring
Time frame: At baseline
Number of pro-arrhythmic effects, (non)-sustained VT or atrial flutter, in AAD arms with frequent visits and use of 24-hour Holter monitoring
Time frame: 3, 6 and 12 months after intervention
QTc prolongation (sotalol) and QRS broadening (flecainide) with requiring frequent checks with standard ECG and/or treadmill test
Time frame: 4-6 weeks after first administration of AAD
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Complication rate of catheter ablation
In all patients with special interest to the subgroup of patients with anatomically challenging origin of (non-RVOT) VPB/VTs
Time frame: Procedure and 3, 6 and 12 months after intervention
Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement)
Time frame: Baseline, 6 and 12 months after intervention
Absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil
Time frame: 3, 6 and 12 months after intervention
Divide patients in three groups depending on HR dependency of VPB/VT and compare absolute and relative difference in VPB/VT burden (%) from baseline, during treatment with sotalol versus treatment with flecainide/verapamil
Time frame: 3, 6 and 12 months after intervention