EUCTR2018-001518-13-NL
Active, not recruiting
Phase 1
Comparison between treatment with catheter ablation or anti-arrhythmic drugs (sotalol or combination of verapamil and flecainide) of patients with benign ventricular premature beats and ventricular tachycardia; a prospective, randomized, multicenter trial - ECTOPIA
Maatschap Cardiologie Zwolle0 sites180 target enrollmentAugust 1, 2018
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Premature ventricular beats, ventricular ectopy, ventricle tachycardia
- Sponsor
- Maatschap Cardiologie Zwolle
- Enrollment
- 180
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Patients willing and capable to provide written informed consent
- •\-Patients with frequent symptomatic VPB/VT and/or nonsustained VTs with a burden of \= 5% on 24 hour Holter monitor AND
- •\-Absence of structural heart disease AND
- •\-Absence of underlying cardiac ischemia 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
Exclusion Criteria
- •\-Age \>75 years
- •\- Previous catheter ablation therapy for VPB/VT
- •\-Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. CPVT, long\- or short QT syndrome, Brugada syndrome)
- •\-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 ALAT or ASAT \= 3 times ULN at screening.
- •\-Untreated hypo\- or hyperthyroidism or electrolyte imbalance
- •\- Untreated obstructive sleep apnea
Outcomes
Primary Outcomes
Not specified
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