[Multi-center clinical trial on efficacy of national-made radiofrequency ablation catheter for the treatment of atrioventricular nodal reentrant tachycardia and atrioventricular reentrant tachycardia].

Objective: The aim of this trial is to compare the efficacy and safety between national-made and imported ablation catheters for the treatment of atrioventricular nodal reentrant tachycardia (AVNRT) and atrioventricular reentrant tachycardia (AVRT).
Method: A total of 1342 patients with AVNRT or AVRT were randomly treated with national-made ablation catheter (Group 1, n = 672) or imported ablation catheter (Group 2, n = 670).
Results: The immediate ablation success rate was similar in Group 1 and Group 2 (97.9% vs. 99.1%, P > 0.05). There were also no significant differences in the procedure time [(68 +/- 36) min vs. (67 +/- 34) min], the fluoroscopic time [(14 +/- 14) min vs. (10 +/- 11) min], the number of energy delivery [(4.5 +/- 4.5) beats vs. (4.6 +/- 3.9) beats], the ablation time [(260 +/- 218) s vs. (257 +/- 207) s] and the score of ablation catheter performance evaluation [(4.4 +/- 0.5) vs. (4.5 +/- 0.4) ] between the two groups (all P > 0.05). Three patients developed pericardial effusion (1 in Group 1 and 2 in Group 2, P > 0.05). Incidence of recurrence of tachycardia during the 3 months follow up was similar between the 2 groups (14 in Group1 vs. 16 in Group 2, P > 0.05).
Conclusion: National-made and imported radiofrequency ablation catheters have similar efficacy and safety for treatment of AVNRT and AVRT.