CompletedNot Applicable

Philips Intracardiac Echocardiography (ICE) Clinical Registry

United States155 participantsStarted 2021-10-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 18 years of age and willing to provide written, dated and signed, informed consent
✓. Scheduled for a procedure that is within the scope of clinical indication for VeriSight per Instructions for Use (IFU)

Exclusion criteria

✕. Contraindicated for ICE catheter placement or patient considerations that make placement of VeriSight not technically feasible
✕. If alternate access (as needed instead of femoral) is not viable
✕. 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.

What they're measuring

Technical Success

Timeframe: During procedure

Imaging Success

Timeframe: During procedure

Clinical Success

Timeframe: During procedure

Number of Participants With Device-related Adverse Event Detection

Timeframe: Procedure through 48 hours or discharge, whichever is earlier

Trial details

NCT IDNCT04950192

SponsorPhilips Clinical & Medical Affairs Global

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-30

Results submitted2024-03-21

View on ClinicalTrials.gov More Atrial Fibrillation trials