ViewFlex X ICE First-in-Human Study

Part of paid clinical trials in Jonesboro, Arkansas.

Sponsor
Abbott Medical Devices
Study ID
NCT06772493
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Arrhythmias

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Dec 16, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Cohort 1
    Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System
  • Arm: Cohort 2
    Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System
  • Arm: Cohort 3
    Single Arm group to undergo a 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 ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
St. Bernards Medical CenterJonesboroArkansas72401
Kayla Rubino
[email protected]
870-935-6729
Devi Nair, MD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoLa JollaCalifornia92037
Jesus Gil
[email protected]
858-246-2405
Jonathan Hsu, MD (PRINCIPAL_INVESTIGATOR)
Ascension St. Vincent's RiversideJacksonvilleFlorida32204-
Research Medical CenterKansas CityMissouri64132
Donita Atkins
[email protected]
(913) 934-4300
Rakesh Gopinathannair, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
April Jacob
[email protected]
212-263-7704
Larry Chinitz, MD (PRINCIPAL_INVESTIGATOR)
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Mary Gnap
[email protected]
215-349-8446
Fermin Garcia, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Krista Szymanski
[email protected]
843-876-6846
Jeffrey Winterfield, MD (PRINCIPAL_INVESTIGATOR)
Houston Methodist HospitalHoustonTexas77030
Chinwe Ngumezi
[email protected]
346-238--290
Amish Dave, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jonesboro, AR

By research site
St. Bernards Medical Center· Jonesboro, ARUniversity of California, San Diego· La Jolla, CAAscension St. Vincent's Riverside· Jacksonville, FLResearch Medical Center· Kansas City, MONYU Langone Health· New York, NYHospital of the University of Pennsylvania· Philadelphia, PA

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