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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotalol | Active Comparator |
| |
| Flecainide and verapamil | Active Comparator |
| |
| Catheter ablation | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotalol | Drug | Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful therapy | Number of patients reaching succesfull therapy defined as >80% reduction of of VPB/VT burden after 3 months | After 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| VPB/VT burden | 3, 6, 12 months after intervention | |
| Change in VPB/VT burden | Measurement in different subgroups e.g.: males, pre and post-menopausal women | Before the intervention (baseline) and 3, 6, 12 months after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arif Elvan, MD, PhD | Isala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala hospital | Zwolle | Netherlands |
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| ID | Term |
|---|---|
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D005117 | Cardiac Complexes, Premature |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013015 | Sotalol |
| D005424 | Flecainide |
| D014700 | Verapamil |
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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Randomized trial comparing catheter ablation with two different potent AADs with different engagement mechanisms in a 1:1:1 ratio with a crossover design in the AAD arm.
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| Flecainide and verapamil | Drug | 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 |
|
| Catheter ablation | Procedure | Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine |
|
| 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. | 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 | 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 | 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 | 4-6 weeks after first administration of AAD |
| 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 | 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) | 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 | 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 | 3, 6 and 12 months after intervention |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |