Evaluation of CARTOSOUND FAM Software for Accurate Reconstruction of the Left Atrium

Evaluation of CARTOSOUND FAM Software for Accurate Three Dimensional Reconstruction of the Left Atrium in Patients Referred for Atrial Fibrillation Ablation

The aim of the present study is to compare the LA reconstruction obtained with CartoSound-FAM software and The M-FAM software to the Carto Merge 3D reconstruction and FAM in consecutive patients referred for AF ablation.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.

Detailed Description

A precise reconstruction of the left atrium (LA), the pulmonary veins (PV) and the left atrial appendage (LAA) is of critical importance in order to achieve efficient and safe results in atrial fibrillation ablation. Currently the LA reconstruction methods are mainly based on techniques as Fast Anatomical Mapping (FAM) and cardiac CT merging. FAM mapping requires catheter manipulation by a skilled operator and it is time consuming. The raw anatomy obtained with FAM requires also a post imaging refinement of the LA surfaces by shaving of the image with sculpting tools before the initiation of the ablation and throughout the procedure. A drawback of this approach is represented by the frequent lack of accuracy in the definition of critical areas of the LA during the ablation as PV antrum, left PVs-LAA appendage ridge, PV carinas. An alternative approach is based on the merging of the FAM reconstruction to a CT scan of the left atrium acquired before the procedure (Carto Merge). The advantage of this technique is a far better definition of the LA anatomy including PV antrum, PV sizing, angle of insertion on the LA of the PV and the recognition of PV anomalies (PV common os, separated branches, additional PVs). The drawbacks of these approaches are mainly related to the exposure of the patients to contrast media during the cardiac CTA and the additional costs of the CT scan to the entire budget of the procedure.

The CARTOSOUND® FAM algorithm is a model-based algorithm, developed using the Machine Learning methodology, which reconstructs a 3D volume of the Left Atrium (LA) anatomies (LA Body, Left Atrial Appendage - LAA, Left Inferior Pulmonary Vein - LIPV, Left Superior Pulmonary Vein - LSPV, Right Superior Pulmonary Vein - RSPV, and Right Inferior Pulmonary Vein - RIPV) based on a series of 2D ultrasound frames acquired from the Right Atrium - RA (Fossa Ovalis) and the RVOT. In addition to the 3D volume reconstructed, the CARTOSOUND® FAM algorithm generates 2D automatic contours that are overlaid on the corresponding 2D ultrasound frames and provides auto segmentation of the Left Atrium (LA) anatomies. The advantages of the CARTOSOUND FAM are related to the shortening of mapping required to achieve an entire LA reconstruction and better resolution of the LA anatomy compared to FAM.

The aim of the present study is to compare the LA reconstruction obtained with CartoSound-FAM software and The M-FAM software to the Carto Merge 3D reconstruction and FAM in consecutive patients referred for AF ablation.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ehud Chorin, MD, PhD; Phone Number: 972527360498; Email: udichorin5@gmail.com

Study Locations

• Israel
  • Tel Aviv, Israel
    • Recruiting
    • Tel Aviv Medical Center
    • Contact: Ehud Chorin, MD, PhD; Phone Number: 972527360498; Email: udichorin5@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female >18 years old.
• Subjects must provide written informed consent to participate in the study.
• Subject is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluations.

Exclusion Criteria:

• Pregnant women.
• Patients with iodine contrast media allergy
• Patients with renal failure (GFR <60ml/min)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M-FAM; Will undergo the procedure with assistance from the M-FAM syetem Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months	Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.; One group will undergo the procedure with assistance from the CartoSound-FAM system and the other with the M-FAM system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Either CartoSound-FAM or M-FAM software systems alongside Carto Merge 3D reconstruction will be used during the treatment for atrial fibrillation. Data will be anonymized by removing patient protected health information, only initials will be used
Experimental: CARTOSOUND-FAM; Will undergo the procedure with assistance from the CARTOSOUND-FAM syetem Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months	Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.; One group will undergo the procedure with assistance from the CartoSound-FAM system and the other with the M-FAM system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Either CartoSound-FAM or M-FAM software systems alongside Carto Merge 3D reconstruction will be used during the treatment for atrial fibrillation. Data will be anonymized by removing patient protected health information, only initials will be used

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time	The time required to map the LA in order to obtain a CartoSound-FAM and the M-FAM reconstructions (in minutes).	1 day
Anatomy accuracy - LAA size	The LAA size and position will be compared for between CT and CartoSound-FAM (diameter in centimeters)	1 week
Anatomy accuracy - LA size	The LA will be compared for between CT and CartoSound-FAM	1 week
Anatomy accuracy - PV position	The PV position will be compared for between CT and CartoSound-FAM	1 week
Anatomy accuracy - LAA position	The LAA position will be compared for between CT and CartoSound-FAM	1 week

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Ehud Chorin, MD, PhD, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: October 2, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 18, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TASMC-05- EC- 0457-20-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The results of the study will be submitted to a peer-reviewed journal in the field of cardiac arrhythmia.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No