Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Clinical Trials in the USA / NCT06772493
Recruiting Observational

ViewFlex X ICE First-in-Human Study

NCT06772493 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2024-12-16
Last updated
2026-06-02

Condition(s) studied

Cardiac Arrhythmias

Investigational drug(s) / intervention(s)

ViewFlex X ICE System

ViewFlex X ICE System: Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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 2. Implanted mechanical mitral or tricuspid valve replacement 3. Implanted intracardiac device within 30 days 4. Pregnant or nursing 5. 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.

Primary outcome measure(s)

  • 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 sites (8)

FacilityCityRegionStatus
St. Bernards Medical Center Jonesboro Arkansas Recruiting
University of California, San Diego La Jolla California Recruiting
Ascension St. Vincent's Riverside Jacksonville Florida Recruiting
Research Medical Center Kansas City Missouri Recruiting
NYU Langone Health New York New York Recruiting
Hospital of the University of Pennsylvania Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
Houston Methodist Hospital Houston Texas Recruiting

More Abbott Medical Devices trials in the USA

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial Active, not recruiting
ASCEND CSP IDE Study Active, not recruiting
Abbott Medical - VERITAS Study Active, not recruiting
Health App Data Collection Study Enrolling by invitation
AVEIR DR Coverage With Evidence Development (CED) Study Active, not recruiting

Other trials for the same condition

EluPro Antibiotic-Eluting BioEnvelope Registry Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06772493 on ClinicalTrials.gov ↗ ← All trials in the USA