Clinical investigation of antiarrhythmic devices. A statement for healthcare professionals from a joint task force of the North American Society of Pacing and Electrophysiology, the American College of Cardiology, the American Heart Association, and the Working Groups on Arrhythmias and Cardiac Pacing of the European Society of Cardiology.
The goal of radiofrequency catheter ablation and the criterion for efficacy is the elimination of arrhythmogenic myocardium. The application of radiofrequency current in the heart clearly results in lower morbidity and mortality rates than thoracic and cardiac surgical procedures in general, and comparisons of therapy with radiofrequency catheter ablation and therapy with thoracic and cardiac surgical procedures in randomized clinical trials is unwarranted. Trials of radiofrequency catheter ablation versus medical or implantable cardioverter-defibrillator therapy may be indicated in certain conditions, such as ventricular tachycardia associated with coronary artery disease. Randomized trials are recommended for new and radical departures in technology that aim to accomplish the same goals as radiofrequency catheter ablation. Surveillance using registries and/or databases is necessary in the assessment of long-term safety and efficacy.
Saksena
S
S
Epstein
A E
AE
Lazzara
R
R
Maloney
J D
JD
Zipes
D P
DP
Benditt
D G
DG
Camm
A J
AJ
Domanski
M J
MJ
Fisher
J D
JD
Gersh
B J
BJ
D000572:American Heart Association; D001145:Arrhythmias, Cardiac / Q000517:prevention & control*; D002304:Cardiac Pacing, Artificial; D017115:Catheter Ablation / Q000295:instrumentation*; D002986:Clinical Trials as Topic; D017147:Defibrillators, Implantable; D018795:Device Approval; D005060:Europe; D006801:Humans; D010138:Pacemaker, Artificial; D018579:Patient Selection; D011358:Product Surveillance, Postmarketing; D012107:Research Design; D012955:Societies, Medical; D014481:United States