Atrial FibrillationNCT04600245
Evaluation of CARTOSOUND FAM Software for Accurate Reconstruction of the Left Atrium
A study testing Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation. in people with Atrial Fibrillation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Oct 2020to 1 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women.
- Patients with iodine contrast media allergy
- Patients with renal failure (GFR <60ml/min)
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Ehud Chorin, MD, PhD, 972527360498, udichorin5@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.Procedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| M-FAM | Experimental | 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 Receives: Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation. |
| CARTOSOUND-FAM | Experimental | 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 Receives: Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
The time required to map the LA in order to obtain a CartoSound-FAM and the M-FAM reconstructions (in minutes).
Measured: 1 day
Anatomy accuracy - LAA size
The LAA size and position will be compared for between CT and CartoSound-FAM (diameter in centimeters)
Measured: 1 week
Anatomy accuracy - LA size
The LA will be compared for between CT and CartoSound-FAM
Measured: 1 week
Anatomy accuracy - PV position
The PV position will be compared for between CT and CartoSound-FAM
Measured: 1 week
Anatomy accuracy - LAA position
The LAA position will be compared for between CT and CartoSound-FAM
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ehud Chorin, MD, PhD, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600245
- Sponsor's protocol ID
- TASMC-05- EC- 0457-20-TLV
- Status last verified
- Oct 2020
- First submitted
- 2 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The results of the study will be submitted to a peer-reviewed journal in the field of cardiac arrhythmia.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CARTOSOUND FAM Software for Accurate Three Dimensional Reconstruction of the Left Atrium in Patients Referred for Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT04600245
- Acronym / sponsor ID
- TASMC-05- EC- 0457-20-TLV
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 23 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. 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
| Arm | Type | Receives |
|---|---|---|
| M-FAM | Experimental | Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.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 |
| CARTOSOUND-FAM | Experimental | Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Pregnant women.
- Patients with iodine contrast media allergy
- Patients with renal failure (GFR <60ml/min)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | CARTOSOUND-FAM, M-FAM |
Primary outcome
Procedure time
Time frame: 1 day
The time required to map the LA in order to obtain a CartoSound-FAM and the M-FAM reconstructions (in minutes).
Anatomy accuracy - LAA size
Time frame: 1 week
The LAA size and position will be compared for between CT and CartoSound-FAM (diameter in centimeters)
Anatomy accuracy - LA size
Time frame: 1 week
The LA will be compared for between CT and CartoSound-FAM
Anatomy accuracy - PV position
Time frame: 1 week
The PV position will be compared for between CT and CartoSound-FAM
Anatomy accuracy - LAA position
Time frame: 1 week
The LAA position will be compared for between CT and CartoSound-FAM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Individual participant dataSharing planned: No. The results of the study will be submitted to a peer-reviewed journal in the field of cardiac arrhythmia.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehud Chorin, MD, PhD principal investigator
Tel Aviv Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation. in people with Atrial Fibrillation, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehud Chorin, MD, PhD (972527360498, udichorin5@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure time (time frame: 1 day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.