ViewFlex X ICE First-in-Human Study

NCT ID: NCT06772493

Last Updated: 2025-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-16

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cardiac Arrhythmias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

Single Arm group to undergo a cardiac ablation procedure utilizing the ViewFlex X ICE System

ViewFlex X ICE System

Intervention Type DEVICE

Subjects to undergo 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

ViewFlex X ICE System

Intervention Type DEVICE

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

Interventions

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ViewFlex X ICE System

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

Intervention Type DEVICE

Eligibility Criteria

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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 investigation.
2. Implanted left atrial appendage occluder
3. Implanted mechanical mitral or tricuspid valve replacement
4. Implanted intracardiac device within 30 days
5. Pregnant or nursing
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristin Ruffner, PhD

Role: STUDY_DIRECTOR

Abbott

Locations

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St. Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status RECRUITING

University of California, San Diego

La Jolla, California, United States

Site Status NOT_YET_RECRUITING

Research Medical Center

Kansas City, Missouri, United States

Site Status NOT_YET_RECRUITING

NYU Langone Health

New York, New York, United States

Site Status NOT_YET_RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Ben Gansemer, PhD

Role: CONTACT

9527152719

Anne Sarver, PhD

Role: CONTACT

Facility Contacts

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Kayla Rubino

Role: primary

870-935-6729

Kendall Oliver

Role: primary

858-246-0217

Donita Atkins

Role: primary

(913) 934-4300

April Jacob

Role: primary

212-263-7704

Chandler Schwede

Role: primary

843-792-5998

Other Identifiers

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ABT-CIP-10528

Identifier Type: -

Identifier Source: org_study_id

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