NCT02303639

Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias

Medical ANtiarrhythmic Treatment or Radiofrequency Ablation in Ischemic Ventricular Tachyarrhythmias. A Prospective, Randomized Multicentre Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Central Finland Hospital District · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses in patients with ischemic heart disease and implantable cardioverter defibrillator.

Detailed description

The study is designed to evaluate whether catheter based radiofrequency ablation is superior to optimized antiarrhythmic medical therapy in preventing ventricular tachyarrhythmia relapses among patients with prior myocardial infarction and implantable cardioverter defibrillator (ICD). The patients have not been using using chronic antiarrhythmic medication. Primary end point is number of ICD therapies (defibrillations, cardioversions and antitachycardia pacing) and otherwise documented sustained ventricular tachycardia (duration more than 30 s or hemodynamically unstable ) or ventricular fibrillation episodes during 12 months follow-up period. Secondary end points include mortality, hospitalization for cardiac reason, health economics, quality of life and several ICD and arrhythmia related issues. Total length of the follow-up is at least two years.

Conditions

• Myocardial Infarction
• Ventricular Tachyarrhythmia

Interventions

Type	Name	Description
PROCEDURE	Radiofrequency catheter ablation	Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping
DRUG	Antiarrhythmic drug therapy	Amiodarone (or sotalol) for prevention of VT/VF relapses

Timeline

• Start date: 2015-04-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2014-12-01
• Last updated: 2016-09-01

Locations

2 sites across 1 country: Finland