Aortic Valve Disease, Atrial Fibrillation, Atrial Septal Defect, Mitral Valve Disease, Patent Foramen Ovale, Stroke, Tricuspid Valve Disease, Valve Disease, Heart
Conditions
Keywords
ICE, Image guided therapy, Structural Heart, Electrophysiology, Intracardiac echocardiography, Atrial Fibrillation, Stroke, Ablation, Valve Disease
Brief 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.
Detailed 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.
Interventions
DEVICEICE Image guidance
ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | During procedure | Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure |
| Imaging Success | During procedure | Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator |
| Clinical Success | During procedure | Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications. |
| Number of Participants With Device-related Adverse Event Detection | Procedure through 48 hours or discharge, whichever is earlier | Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prospective Observational Prospective observational subjects undergoing planned cardiac procedures utilizing image guidance
ICE Image guidance: ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures | 155 |
| Total | 155 |
Baseline characteristics
| Characteristic | Prospective Observational |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 103 Participants |
| Age, Categorical Between 18 and 65 years | 52 Participants |
| Age, Continuous | 68.1 years STANDARD_DEVIATION 14.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 125 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 32 Participants |
| Race (NIH/OMB) White | 112 Participants |
| Region of Enrollment United States | 155 Participants |
| Sex: Female, Male Female | 67 Participants |
| Sex: Female, Male Male | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 155 |
| other Total, other adverse events | 0 / 155 |
| serious Total, serious adverse events | 0 / 155 |
Outcome results
Primary
Clinical Success
Investigator's assessment (Y/N) on adequacy of VeriSight imaging for visualization of major cardiac structures, and guiding procedural intervention, and ability to detect/ assess intra-procedural complications.
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Observational | Clinical Success | 149 Participants |
Primary
Imaging Success
Adequate image quality via Likert scale ( Acceptable or better) as determined by the investigator
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Observational | Imaging Success | 147 Participants |
Primary
Number of Participants With Device-related Adverse Event Detection
Detect device-related adverse events periprocedural through discharge or ≤48 hours post-procedure, whichever is earlier.
Time frame: Procedure through 48 hours or discharge, whichever is earlier
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Observational | Number of Participants With Device-related Adverse Event Detection | 0 Participants |
Primary
Technical Success
Investigator's assessment (Y/N) on successful delivery of VeriSight to the target intracardiac position and sustained device operation during the procedure
Time frame: During procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Observational | Technical Success | 153 Participants |