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CARDIOVASCULAR
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Clinical Evidence

WHEN YOU CHECK FOR GAPS IN PULMONARY VEIN ISOLATION, ARE YOU SEEING THEM ALL?

 

Acute data collection that includes both direct and indirect comparisons of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in standard pulmonary vein isolation (PVI) confirmation workflows suggests that the device can identify gaps that may be missed by other technologies.

Circular Mapping Cathethers1

The incidence and location of gaps following PVI were tracked utilizing either a 10-pole circular mapping catheter (CMC10), a 20-pole circular mapping catheter (CMC20) or the Advisor™ HD Grid Mapping Catheter, SE.

Isolation was tracked across 99 cases

Advisor HD Grid Mapping Catheter, SE (n=33) 81.8% of patients had gaps. 2.15 gaps per patient.

Cryoablation2

In a direct comparison, 18 patients received cryoablation with isolation confirmed by the Achieve Mapping Catheter. Isolation was then checked again with the Advisor HD Grid Mapping Catheter, SE, revealing:

4 patients with greater than or equal to 1 gap missed by the Achieve Mapping Catheter.
12 total gaps missed by the Achieve Mapping Catheter were identified by the Advisor HD Grid Mapping Catheter, SE.

Pacing Ablation Line3

In a direct comparison, 22 patients received ablation with isolation confirmed by pacing the ablation line. Isolation was then checked again with the Advisor HD Grid Mapping Catheter, SE, revealing:

15 patients with greater than or equal to 1 gap missed by pacing.
30 total gaps missed by pacing were identified by the Advisor HD Grid Mapping Catheter, SE.

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Comparison of Gap Identification Using Three Technologies for Confirmation of Pulmonary Vein Isolation

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Incidence and Location of PVI Gaps Identified Post Cryoballoon Ablation for Atrial Fibrillation

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Incidence and Location of Residual Gaps Identified by a High Density Grid Style Mapping Catheter After PVI Is Confirmed by Pacing the Ablation Lines

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Close the Gap Infographic

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Close the Gap: Clinical Evidence
This document references three clinical studies for Advisor HD Grid Mapping Catheter, Sensor Enabled, sharing truncated links to the studies.

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References

  1. Porterfield C, et al. Comparison of Gap Identification Using Three Technologies for Confirmation of Pulmonary Vein Isolation. Originally scheduled for poster presentation at EHRA 2020 Congress. Abbott. Data on File: MAT-2002108 v1.0.
  2. Eldadah Z, et al. Incidence and Location of PVI Gaps Identified Post-Cryoballoon Ablation for Atrial Fibrillation. Originally scheduled for poster presentation at EHRA 2020 Congress. Abbott. Data on File: MAT-2002103 v1.0.
  3. Giuggia M, et al. Incidence and Location of Residual Gaps Identified by a High-Density Grid-Style Mapping Catheter After PVI Is Confirmed by Pacing the Ablation Lines. Originally scheduled for poster presentation at EHRA 2020 Congress. Abbott. Data on File: MAT-2002112 v1.0.

MAT-2007563 v1.0

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