Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System

Conavi1 site in 1 country10 target enrollmentSeptember 2015

ConditionsAtrial Fibrillation

Overview

Phase: Early Phase 1
Intervention: Not specified
Conditions: Atrial Fibrillation
Sponsor: Conavi
Enrollment: 10
Locations: 1
Primary Endpoint: Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the efficacy of 2D forward-looking and 3D Intracardiac Echocardiography (ICE) to guide septal punctures during Atrial Fibrillation ablation procedures.

Detailed Description

This study is part of a multiphase study. Phase 1 involves 10 patients at a single centre. Phase 2 will be done a multi centre study.

Registry

clinicaltrials.gov

Start Date

September 2015

End Date

May 5, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Conavi

Responsible Party

Sponsor

Eligibility Criteria

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 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.