Recruiting

ViewFlex X ICE System

Sponsor:

Abbott Medical Devices

Code:

NCT06772493

Conditions

Cardiac Arrhythmias

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ViewFlex X ICE System

Study Details

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).

Conditions

Cardiac Arrhythmias

Study ID

NCT06772493

Start date

Dec 16, 2024

Status verified date

May, 2026

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

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

ViewFlex X ICE System

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Ben Gansemer, PhD

9527152719benjamin.gansemer@abbott.com

Amber Miller, PhD

amber.miller@abbott.com

Locations

St. Bernards Medical Center

Recruiting

Jonesboro, Arkansas, United States, 72401

Contacts

Kayla Rubino

870-935-6729krubino@dnairresearch.com

Principal Investigator:

Devi Nair, MD

University of California, San Diego

Recruiting

La Jolla, California, United States, 92037

Contacts

Jesus Gil

858-246-2405jegil@health.ucsd.edu

Principal Investigator:

Jonathan Hsu, MD

Ascension St. Vincent's Riverside

Recruiting

Jacksonville, Florida, United States, 32204

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

Donita Atkins

(913) 934-4300Donita.Atkins@HCAHealthcare.com

Principal Investigator:

Rakesh Gopinathannair, MD

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

April Jacob

212-263-7704april.jacob@nyulangone.org

Principal Investigator:

Larry Chinitz, MD

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Mary Gnap

215-349-8446mary.gnap@pennmedicine.upenn.edu

Principal Investigator:

Fermin Garcia, MD

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Krista Szymanski

843-876-6846szymanski@musc.edu

Principal Investigator:

Jeffrey Winterfield, MD

Houston Methodist Hospital

Recruiting

Houston, Texas, United States, 77030

Contacts

Chinwe Ngumezi

346-238--290ccngumezi@houstonmethodist.org

Principal Investigator:

Amish Dave, MD

More Information

Sponsor

Abbott Medical Devices

Last update posted

Jun 2, 2026

Last verified

May, 2026

Keywords

  • Intracardiac Echocardiography
  • cardiac electrophysiology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abbott Medical Devices on 2026-06-02.