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    • 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.

    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 plus

    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

    Educational resources on Medtronic Academy

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