RECRUITING

ViewFlex X ICE First-in-Human Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

ViewFlex X ICE First-in-Human Study

Quick Facts

Study Start:2024-12-16
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06772493

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Able and willing to provide written informed consent prior to any clinical investigation-related procedure.
  2. 2. Plans to undergo any EP procedure utilizing ICE
  3. 3. At least 18 years of age
  1. 1. Subject is currently participating in another clinical investigation.
  2. 2. Implanted left atrial appendage occluder
  3. 3. Implanted mechanical mitral or tricuspid valve replacement
  4. 4. Implanted intracardiac device within 30 days
  5. 5. Pregnant or nursing
  6. 6. 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.

Contacts and Locations

Study Contact

Ben Gansemer, PhD
CONTACT
9527152719
benjamin.gansemer@abbott.com
Anne Sarver, PhD
CONTACT
anne.sarver@abbott.com

Principal Investigator

Kristin Ruffner, PhD
STUDY_DIRECTOR
Abbott

Study Locations (Sites)

St. Bernards Medical Center
Jonesboro, Arkansas, 72401
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Kristin Ruffner, PhD, STUDY_DIRECTOR, Abbott

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-16
Study Completion Date2025-12

Study Record Updates

Study Start Date2024-12-16
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Intracardiac Echocardiography
  • cardiac electrophysiology

Additional Relevant MeSH Terms

  • Cardiac Arrhythmias