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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04950192
Other study ID # 2019_10745
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 25, 2021
Est. completion date July 30, 2024

Study information

Verified date March 2024
Source Philips Clinical & Medical Affairs Global
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this observational registry is to report real-world safety and performance of VeriSight for ultrasound guided ICE imaging in percutaneous cardiac intervention procedures when used in standard clinical practice.


Description:

This is a prospective, multi-center, observational, single-arm registry intended to gather real-world data to report VeriSight ICE catheter performance and safety. It will be conducted in the United States under the approval of one or more recognized institutional review boards and in compliance with Good Clinical Practice guidelines defined in International Standards Organization:14155;2011, the Declaration of Helsinki, and all applicable federal and local laws and regulations. Only on label uses of the VeriSight ICE catheter will be allowed. No specific claims are being validated during this registry, though data analyzed from this protocol are intended to inform of future claims regarding the performance and safety of the VeriSight catheter. Enrolled patients will be imaged with VeriSight for various types of percutaneous cardiac interventional procedures. Enrolled subjects will be followed until discharge or ≤48 hrs post-procedure. The registry has a planned duration of approximately 24-36 months with interim analysis planned at 100 patients before further enrollment will be considered. Statistical hypotheses are not intended for this registry and descriptive analysis will be conducted. Data from all clinical sites are intended to be pooled for analysis. It is possible that sub-analyses may be conducted to demonstrate VeriSight guidance for target intervention types in structural heart and electrophysiology procedures.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 155
Est. completion date July 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. 18 years of age and willing to provide written, dated and signed, informed consent 2. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU) Exclusion Criteria: 1. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible 2. If alternate access (as needed instead of femoral) is not viable 3. Known contraindicated conditions include sepsis, major coagulation abnormalities, presence of any intracardiac thrombus, presence of class IV angina or heart failure, deep vein thrombosis, or significant peripheral vascular disease.

Study Design


Intervention

Device:
ICE Image guidance
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures

Locations

Country Name City State
United States University of Colorado Aurora Colorado
United States Texas Cardiac Arrhythmia Research Foundation Austin Texas
United States Massachusetts General Hospital Boston Massachusetts
United States Northwestern University Chicago Illinois
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Philips Clinical & Medical Affairs Global

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical Success Successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure During procedure
Primary Imaging Success Adequate image quality as determined by the investigator. During procedure
Primary Clinical Success Adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. During procedure
Primary Device-related adverse event detection Detect device-related adverse events periprocedural through discharge or =48 hours post-procedure, whichever is earlier. Procedure through 48 hours or discharge, whichever is earlier
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