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Foresight Intracardiac Echocardiography System (ICE)

C

Conavi

Status and phase

Completed
Phase 1

Conditions

Atrial Fibrillation

Treatments

Device: Intracardiac echocardiography imaging

Study type

Interventional

Funder types

Industry

Identifiers

NCT03239444
EXT-001-1.5

Details and patient eligibility

About

This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.

Full description

The study will recruit 10 patients at a single center.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patient is at least 18 years old.
  • Patient is undergoing an atrial fibrillation ablation procedure.
  • Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
  • Patient provides informed, written consent for participation in the study.

Exclusion criteria

  • Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure).
  • Patients in whom transseptal puncture is relatively contraindicated.
  • Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
  • Women of child bearing potential, in whom pregnancy cannot be excluded.
  • Patients unable to grant informed, written consent for participation in the study.

Trial design

Primary purpose

Device Feasibility

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

Assigned Intervention
Other group
Description:
Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure.
Treatment:
Device: Intracardiac echocardiography imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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