What this study is
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).
What's being tested
- ViewFlex X ICE System
Intervention · DEVICE
Subjects to undergo cardiac ablation procedure utilizing the ViewFlex X ICE System
Study details
- Sponsor
- Abbott Medical Devices
- Conditions
- Cardiac Arrhythmias
- Enrolling
- 500 people
- Starts
- 2024-12-16
- Est. completion
- 2026-06
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (8)
8 openSt. Bernards Medical Center
Jonesboro, Arkansas, United States
- Kayla Rubino · Contact870-935-6729krubino@dnairresearch.com
- Devi Nair, MD · Principal investigator
RecruitingUniversity of California, San Diego
La Jolla, California, United States
- Jesus Gil · Contact858-246-2405jegil@health.ucsd.edu
- Jonathan Hsu, MD · Principal investigator
RecruitingAscension St. Vincent's Riverside
Jacksonville, Florida, United States
RecruitingResearch Medical Center
Kansas City, Missouri, United States
- Donita Atkins · Contact(913) 934-4300Donita.Atkins@HCAHealthcare.com
- Rakesh Gopinathannair, MD · Principal investigator
RecruitingNYU Langone Health
New York, New York, United States
- April Jacob · Contact212-263-7704april.jacob@nyulangone.org
- Larry Chinitz, MD · Principal investigator
RecruitingHospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
- Mary Gnap · Contact215-349-8446mary.gnap@pennmedicine.upenn.edu
- Fermin Garcia, MD · Principal investigator
RecruitingMedical University of South Carolina
Charleston, South Carolina, United States
- Krista Szymanski · Contact843-876-6846szymanski@musc.edu
- Jeffrey Winterfield, MD · Principal investigator
RecruitingHouston Methodist Hospital
Houston, Texas, United States
- Chinwe Ngumezi · Contact346-238--290ccngumezi@houstonmethodist.org
- Amish Dave, MD · Principal investigator
Recruiting
Study team
Sponsor
Abbott Medical Devices
Study ID ABT-CIP-10528
Study director
Kristin Ruffner, PhD
Abbott
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.