ViewFlex X ICE First-in-Human Study

Recruiting

• Conditions: Cardiac Arrhythmias

• Registration Number: NCT06772493
• Lead Sponsor: Abbott Medical Devices

Brief Summary

This prospective, acute, first-in-human, non-significant risk study is intended to evaluate a modified version of the ViewFlex X ICE Catheter, Sensor Enabled (ViewFlex X SE) and ViewMate Multi Ultrasound Console (VMM) ICE data integration with the EnSite X EP System (hereafter referred to as the ViewFlex X ICE System).

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-16
• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-10
• Study First Posted: 2025-01-13
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-29
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

A patient will be eligible for clinical trial participation if they meet the following criteria:

1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
2. Plans to undergo any EP procedure utilizing ICE
3. At least 18 years of age

Exclusion Criteria

A patient will be excluded from enrollment in the study if they meet any of the following criteria:

1. Subject is currently participating in another clinical investigation.
2. Implanted left atrial appendage occluder
3. Implanted mechanical mitral or tricuspid valve replacement
4. Implanted intracardiac device within 30 days
5. Pregnant or nursing
6. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physician assessment of the ability to navigate the ViewFlex X SE catheter and adequately visualize major cardiac anatomic structures.	During the procedure
Physician assessment of the ability to use anatomic ICE markers and ICE geometry as a reference during mapping and ablation procedures.	during the procedure
Rate of device- or procedure-related serious adverse events that occur through patient discharge.	during the procedure and periprocedurally

Trial Locations

Locations (5)

University of California, San Diego; 🇺🇸 La Jolla, California, United States

Research Medical Center; 🇺🇸 Kansas City, Missouri, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

St. Bernards Medical Center; 🇺🇸 Jonesboro, Arkansas, United States