N/A
Completed N=14
INtra-procedural ultraSound Imaging During Pulmonary Veins Isolation
Source: ClinicalTrials.gov NCT03372798 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames — 22.18; 23.15; 27.04; 27.09 percentage
Summary
One of the biggest limitations of the currently used percutaneous techniques for Pulmonary Vein Isolation (PVI) in the setting of atrial fibrillation ablation is the lack of real-time information about the left atrial (LA) wall thickness and about its acute changes during energy delivery for ablation. This makes difficult to predict the achievement of transmural lesions, to identify the possible causes of ablation failure and also to avoid the occurrence of perforation and/or other collateral damage.
Computed tomography (CT) is a reliable technique for measurement of the LA wall thickness but it cannot be used during the ablation procedure and its extensive use is limited by the need of ionizing radiation. Preliminary data from animal studies support the accuracy of real-time ultrasound imaging modalities such as intracardiac echocardiography (ICE) or Intravascular Ultrasound (IVUS) imaging for measurement of LA wall thickness and monitoring of its acute changes related to catheter ablation.
The pilot study INSIDE PVs has been primarily designed to evaluate the feasibility and accuracy of intravascular imaging techniques for real-time imaging of the LA wall thickness during AF ablation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Measurement of Left Atrial (LA) Wall Thickness on ICE/IVUS Frames |
22.18; 23.15; 27.04; 27.09 | — |
| PRIMARY Measurement of LA Wall Thickness on CT Scans |
— | — |
| SECONDARY Mean Time Required for ICE/IVUS for Real Time Imaging of the Left Atrial (LA) Wall Thickness During AF Ablation |
24.8; 25 | — |
| SECONDARY Number of ICE/IVUS Cases of Good Quality |
24; 0 | — |
Eligibility Criteria
- Inclusion Criteria
- Males older than 40 years or females older than 40 and sterile or in post-menopausal age;
- willing and able to give informed consent for participation in the study;
- history of symptomatic and drug-refractory paroxysmal atrial fibrillation (AF);
- planned AF ablation on a clinical basis.
- Exclusion Criteria
- age less than 40 years and more than 80 years;
- pregnancy, trying for a baby or breast feeding;
- any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study;
- documented allergy to iodinated contrast medium;
- renal insufficiency (eGFR<30);
- weight exceeding the maximum load of the scanner (250kg).
Data sourced from ClinicalTrials.gov (NCT03372798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.