Study Results
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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RECRUITING
200 participants
OBSERVATIONAL
2024-12-16
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
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
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
Eligibility Criteria
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Inclusion 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
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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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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
University of California, San Diego
La Jolla, California, United States
Research Medical Center
Kansas City, Missouri, United States
NYU Langone Health
New York, New York, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ABT-CIP-10528
Identifier Type: -
Identifier Source: org_study_id
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