ViewFlex X ICE First-in-Human Study
ViewFlex X FIH
1 other identifier
observational
500
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2024
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 16, 2024
CompletedFirst Submitted
Initial submission to the registry
January 2, 2025
CompletedFirst Posted
Study publicly available on registry
January 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
March 19, 2026
March 1, 2026
1.5 years
January 2, 2025
March 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (3)
Cohort 1
Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System
Cohort 2
Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System
Cohort 3
Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System
Interventions
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Eligibility Criteria
This clinical investigation will enroll subjects of all genders over the age of 18 undergoing any previously planned electrophysiology study procedure utilizing ICE.
You may qualify if:
- A patient will be eligible for clinical trial participation if they meet the following criteria:
- Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
- Plans to undergo any EP procedure utilizing ICE
- At least 18 years of age
You may not qualify if:
- A patient will be excluded from enrollment in the study if they meet any of the following criteria:
- Subject is currently participating in another clinical trial with an active treatment arm or has participated in such a clinical trial within 30 days prior to enrollment that may interfere with this clinical trial without pre-approval from this study Sponsor
- Implanted mechanical mitral or tricuspid valve replacement
- Implanted intracardiac device within 30 days
- Pregnant or nursing
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
St. Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
University of California, San Diego
La Jolla, California, 92037, United States
Research Medical Center
Kansas City, Missouri, 64132, United States
NYU Langone Health
New York, New York, 10016, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kristin Ruffner, PhD
Abbott
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 2, 2025
First Posted
January 13, 2025
Study Start
December 16, 2024
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
March 19, 2026
Record last verified: 2026-03