Comparison of antiarrhythmic medication and catheter ablation in treatment of life threatening ventricular tachyarrhythmias

Phase 1

• Conditions: Ventricular tachyarrhtyhmias in patients with prior myocardial infarction and implantable cardioverter defibrillator; MedDRA version: 17.1Level: LLTClassification code 10007518Term: Cardiac arrhythmiaSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-004954-33-DK
• Lead Sponsor: Central Finland Hospital District

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-09
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients 18-80 years of age with prior myocardial infarction and ICD or ICD with biventricular pacing capability (CRT-D) for primary or secondary prevention of sudden cardiac death (SCD), who have had at least two documented episodes of sustained VT or VF and no chronic amiodarone treatment for ventricular tachyarrhythmias, are eligible to participate in the study. The last VT/VF episode should be documented in the foregoing 12 months either ECG or by the device. All patients will give written informed consent for the study before randomization.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

Exclusion Criteria

Age less than 18 years or more than 80 years
Non-ischemic cardiomyopathy
Ongoing chronic treatment of ventricular tachyarrhytmias with amiodarone
Intolerance/contraindication to all class III antiarrhythmic drugs (i.e., intolerance/contraindication to one class III agents is not excluding the patient if another one can be used)
Contraindication to endocardial catheter ablation (e.g., intracavitary thrombi, contraindication to perioperative anticoagulation)
Previous VT/VF ablation
Open heart surgery within 3 months
Prosthetic heart valve
Planned revascularization (PCI or CABG), surgery for structural heart disease or heart transplantation
Pregnancy or planned pregnancy within the follow-up period
Secondary cause for VT/VF (e.g., acute myocardial infarction)
Patient does not want to participate
Life expectancy less than 12 months

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified