Ventricular Premature Beats Clinical Trial
— ECTOPIAOfficial title:
Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment
| Verified date | July 2022 |
| Source | Maatschap Cardiologie Zwolle |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | January 17, 2023 |
| Est. primary completion date | January 17, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 76 Years and older |
| Eligibility | Inclusion Criteria: - Patients willing and capable to provide written informed consent - Patients with frequent symptomatic VPB and/or nonsustained VTs with burden = 5% on 24 hour Holter monitor AND - Absence of structural heart disease (excluded by echocardiogram) AND - Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND - Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician. - For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study Exclusion Criteria: - Age >75 years - Previous catheter ablation therapy for VPB/VT - Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome) - Wolff-parkinson-white (WPW) syndrome - Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol. - Left ventricular dysfunction (LV ejection fraction <55%) - Estimated glomerular filtration rate < 50 ml/min/1.73 m2 - Hepatic impairment defined by a total bilirubin = 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) = 3 times ULN at screening - Untreated hypo- or hyperthyroidism or electrolyte imbalance - Untreated obstructive sleep apnea - Patients with history of myocardial infarction or bypass surgery - More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe) - Contraindication for any of the antiarrhythmic drugs used in this study - Enrolment in another clinical study - Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age - Mental or physical inability to participate in the study - Life expectancy = 12 months |
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Isala hospital | Zwolle |
| Lead Sponsor | Collaborator |
|---|---|
| Maatschap Cardiologie Zwolle |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Successful therapy | Number of patients reaching succesfull therapy defined as >80% reduction of of VPB/VT burden after 3 months | After 3 months | |
| Secondary | VPB/VT burden | 3, 6, 12 months after intervention | ||
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | 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 | |
| Secondary | Extended evaluation of left ventricular function with transthoracic echo (TTE) (including global longitudinal strain rate measurement) | Baseline, 6 and 12 months after intervention | ||
| Secondary | 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 | ||
| Secondary | 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 |