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Clinical Trials/NCT02514876
NCT02514876CompletedEarly Phase 1

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

Conavi2 sites in 1 country10 target enrollmentStarted: September 1, 2015Last updated:
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Conditions

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Sponsor
Conavi
Enrollment
10
Locations
2
Primary Endpoint
Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Successful transseptal puncture during atrial fibrillation ablation procedure under the guidance of study device

Time Frame: During ablation procedure (2-4 h)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Conavi
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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