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

NCT04600245 | Unknown

• 1 other identifier: TASMC-05- EC- 0457-20-TLV
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

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

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

Procedure: Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.

Interventions

Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation. PROCEDURE

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

CARTOSOUND-FAM; M-FAM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehud Chorin, MD, PhD

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ehud Chorin, MD, PhD

CONTACT

972527360498; udichorin5@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 23, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2023
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)