Evaluation of 4D Intracardiac Echocardiography (ICE) During Structural Heart and Electrophysiology Procedures (4D-ICE)
Assessment of Utility of Siemens Healthineers 4D ICE and Premium CV System Workflow in Evaluation of Cardiac Anatomy and Physiology During Electrophysiology and Structural Heart Procedures
The purpose of this study is to evaluate the imaging performance and procedural safety of a prototype 4D ICE catheter during real-time intracardiac imaging and to optimize device imaging parameters, compared with current standard imaging modalities.
TEE is the current standard of care and will serve as the primary imaging modality for clinical guidance during the EP and Structural Heart Disease (SHD) procedures. In this research protocol, TEE is not being investigated. ICE will be used as an adjunct imaging modality for research data collection and workflow evaluation only. All procedures will be performed using commercially available, FDA-approved Watchman devices, and no investigational implantable devices will be used. The use of ICE in this study does not modify the approved therapeutic device indication, implantation technique, or standard clinical decision-making.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This study is a prospective clinical feasibility study designed to evaluate the imaging performance, workflow efficiency, and safety of a prototype 4D intracardiac echocardiography (ICE) catheter (ACUNAV Luxera) used in conjunction with the Siemens Premium CV ultrasound system during cardiac interventional procedures.
The ACUNAV Luxera 4D ICE system will be used adjunctively while standard-of-care transesophageal echocardiography (TEE) serves as the primary imaging modality. The study aims to determine whether 4D ICE provides comparable image quality and measurement accuracy to TEE, while maintaining procedural safety and enabling optimization of intracardiac imaging workflows.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Walid Saliba, MD
- Numero di telefono: 216-444-6810
- Email: salibaw@ccf.org
Luoghi di studio
-
-
Ohio
-
Cleveland, Ohio, Stati Uniti, 44195
- Reclutamento
- Cleveland Clinical Foundation
-
Sub-investigatore:
- Oussama Wazni, MD
-
Contatto:
- Walid Saliba, MD
- Numero di telefono: 216-444-6810
- Email: salibaw@ccf.org
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Be aged above 18 for adult participants
- Be scheduled for a LAAO transcatheter procedure with or without concurrent procedures.
- Be able and willing to give informed consent
- (For concomitant cases only) Ablation will occur prior to LAAO implantation
Exclusion Criteria:
Potential subjects must not include:
- Subjects who are currently enrolled in any other investigational clinical studies
- Subjects with any bleeding diathesis
- Subjects with known vascular abnormality rendering right heart catheterization from right or left femoral vein impossible.
- Subjects with known intracardiac thrombus
- Subjects with myocardial infarction within the prior two months
- Subjects with class IV angina or heart failure
- Subjects with sepsis or active infection
- Subjects with immune-deficiency or immune-compromised status
- Subjects with cerebral ischemic event in the prior six months
- Subjects with deep vein thrombosis
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 4D ICE Adjunct Imaging
Participants undergoing left atrial appendage occlusion (LAAO) procedures (with or without concomitant electrophysiology procedures) will receive adjunctive imaging using the 4D ICE catheter while TEE remains the primary imaging modality for procedural guidance.
|
Use of investigational 4D ICE catheter for real-time intracardiac imaging during cardiac interventional procedures, performed adjunctively to standard-of-care TEE guidance.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Feasibility of 4D ICE Imaging Performance
Lasso di tempo: During the Procedure
|
A composite score evaluating the overall technical and clinical adequacy of the 4D Intracardiac Echocardiography (ICE) catheter compared to standard-of-care imaging. The composite score is derived from three individual component assessments: Image Quality: Clarity, resolution, and artifact presence. Anatomical Visualization: Ability to clearly identify target cardiac structures. Procedural Guidance: Effectiveness of real-time images in guiding the procedure. Each component is graded by independent reviewers on a 5-point Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent). The final composite score is calculated as the sum of the three component scores, ranging from a minimum of 3 (worst performance) to a maximum of 15 (best performance). |
During the Procedure
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Image Quality Assessment
Lasso di tempo: During the Procedure
|
Evaluation of 2D, 4D, and Doppler imaging quality using Likert scale (1=Inadequate, 2=Suboptimal, 3=Adequate, 4=Good, 5=Excellent).
|
During the Procedure
|
|
Workflow Efficiency
Lasso di tempo: During the Procedure
|
Procedural workflow metrics including imaging setup and acquisition time
|
During the Procedure
|
|
Measurement Acccuacy
Lasso di tempo: During the Procedure
|
Quantitative comparison of ICE-derived measurements (e.g., LAA sizing) with reference imaging (TEE or CT)
|
During the Procedure
|
|
Safety Outcomes
Lasso di tempo: Up to 45 ± 15 days follow-up
|
Incidence of device- or procedure-related adverse events
|
Up to 45 ± 15 days follow-up
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Walid Saliba, MD, The Cleveland Clinic
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 26-552
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .