Cardiac ablation and mapping
ICY-AVNRT trial
The ICY-AVNRT trial evaluated the safety and effectiveness of the Freezor™ Xtra cardiac cryoablation catheter for the treatment of patients with AVNRT.
Study purpose and design
The ICY-AVNRT trial is a prospective, unblinded, multicenter, single-arm, nonrandomized study evaluating the use of the Freezor Xtra cardiac cryoablation catheter for the treatment of AVNRT; 397 patients enrolled from 36 centers in the United States and Canada.
Key findings
Primary efficacy endpoint met
- Acute success was achieved in 378 of 397 (95%) of subjects
- Chronic success was achieved in 93% of subjects
10 subjects (2.7%) had documented recurrent AVNRT over the six-month follow-up period, all of which occurred within three months of the index procedure.
Primary safety endpoint met
- 4 of 397 (1.0%) subjects experienced a procedure-related safety event
- Procedure-related safety events included:
- One tamponade*
- One pulmonary embolism*
- One femoral vein hemorrhage*
- One diagnostic EP catheter knotting*
- AV block: First-degree AV block persisted beyond follow-up in one subject. No subject was symptomatic, and none required permanent pacing.
* None were related to catheter use.
0%
of AVNRT cases resulted in permanent pacemaker implantation
1%
of AVNRT cases experienced a primary safety event, none of which resulted from the Freezor™ Xtra catheter
92.6%
freedom
from
AVNRT
at six months
Endpoint definitions
Effectiveness
- Acute success is defined as no more than a single echo beat after ablation with or without infusion of isoproterenol
- Chronic success is defined as the composite of acute success and the lack of documented recurrent AVNRT during the six-month follow-up period
Safety
The primary safety endpoint is lack of a serious procedure-related or serious device-related adverse event during the study period
Study population
Key inclusion criteria
- Documented SVT thought to be AVNRT (documented by ECG, transtelephonic, Holter, or event monitors)
- Age 18+
Key exclusion criteria
- History of a sustained VT
- Presence of another supraventricular arrhythmia (SVT) that could be misinterpreted with AVNRT during follow-up
- A reversible cause of SVT
- A previous ablation for AVNRT
- New York Heart Association (NYHA) class III or IV heart failure within the preceding 90 days
- The presence of a permanent implantable cardiac rhythm device (including loop recorders)
- History of AV conduction disturbances, including first-/second-/third-degree AV block or left bundle branch block
Related products
Contact us
Educational resources on
Medtronic Academy
Access detailed product information, including spec sheets, videos, and presentations.