Trial Outcomes & Findings for Model Based Fast Anatomical Mapping (NCT NCT03349476)

Last Updated: 2023-11-29

Results Overview

mMap Scoring Questionnaire: Tool used by operators to rate the accuracy of the map based on the distance between ablation points and accuracy of anatomy compared to the mapped mFam geometry. Total score from 1-7, with lower score indicating not representing (misleading) and higher score indicating agreement (accurate)

Recruitment status

TERMINATED

Study phase

Target enrollment

109 participants

Primary outcome timeframe

hospital discharge, average 24 hours post procedure

Results posted on

2023-11-29

Participant Flow

Participant milestones

Participant milestones
Measure	MFAM The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Overall Study STARTED	109
Overall Study COMPLETED	106
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	MFAM The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Overall Study Physician Decision	3

Baseline Characteristics

Model Based Fast Anatomical Mapping

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MFAM n=109 Participants The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Age, Continuous	68.7 years STANDARD_DEVIATION 9.3 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	104 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: hospital discharge, average 24 hours post procedure

Outcome measures

Outcome measures
Measure	MFAM n=109 Participants The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
mMap Scoring Questionnaire	5.3 score on a scale Standard Deviation 0.19

SECONDARY outcome

Timeframe: during the procedure up to 60 minutes

The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure

Outcome measures

Outcome measures
Measure	MFAM n=109 Participants The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Left Atrial Geometry Creation Time	6.4 minutes Standard Deviation 0.25

SECONDARY outcome

Timeframe: hospital discharge, average 24 hours post procedure

Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure

Outcome measures

Outcome measures
Measure	MFAM n=109 Participants The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Fluoroscopy Time	10.3 seconds Standard Deviation 33.5

Adverse Events

MFAM

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MFAM n=109 participants at risk The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Respiratory, thoracic and mediastinal disorders Acute Respiratory Failure	0.92% 1/109 • 24 hours
Respiratory, thoracic and mediastinal disorders Right Lower Lobe Pneumonia	0.92% 1/109 • 24 hours

Other adverse events

Other adverse events
Measure	MFAM n=109 participants at risk The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter. The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure. MFAM: Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure. mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy
Renal and urinary disorders Urinary Retention	0.92% 1/109 • 24 hours
Cardiac disorders Recurrent Atrial Fibrillation	0.92% 1/109 • 24 hours

Additional Information

Stephanie Harcum

Icahn School of Medicine at Mount Sinai

Phone: (212) 824-8927

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place