Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent
Brief summary
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.
Detailed description
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation. Specifically, the study will assess the following issues in atrial fibrillation ablation: 1. Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry) 2. Left atrial geometry creation time 3. Fluoroscopy time The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques
Interventions
DEVICEMFAM
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
Sponsors
Biosense Webster, Inc.
Vivek Reddy
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Have AF as follows: 1. Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting \< 7 days. 2. Persistent AF - defined as AF that is sustained \> 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes. * Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed) * Have the ability to understand the requirements of the study and sign the informed consent form. * Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements
Exclusion criteria
* Rheumatic heart disease, * Current intra-cardiac thrombus * Class IV HF * Unable to sign consent * Unstable angina * Recent cerebral ischemic events * Contradiction to anticoagulation * Prior cardiac surgery * Complex congenital heart disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mMap Scoring Questionnaire | hospital discharge, average 24 hours post procedure | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Left Atrial Geometry Creation Time | 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 |
| Fluoroscopy Time | hospital discharge, average 24 hours post procedure | Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 109 |
| Total | 109 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 3 |
Baseline characteristics
| Characteristic | MFAM |
|---|---|
| Age, Continuous | 68.7 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 104 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 104 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 109 |
| other Total, other adverse events | 2 / 109 |
| serious Total, serious adverse events | 1 / 109 |
Outcome results
Primary
mMap Scoring Questionnaire
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)
Time frame: hospital discharge, average 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MFAM | mMap Scoring Questionnaire | 5.3 score on a scale | Standard Deviation 0.19 |
Secondary
Fluoroscopy Time
Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure
Time frame: hospital discharge, average 24 hours post procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MFAM | Fluoroscopy Time | 10.3 seconds | Standard Deviation 33.5 |
Secondary
Left Atrial Geometry Creation Time
The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure
Time frame: during the procedure up to 60 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MFAM | Left Atrial Geometry Creation Time | 6.4 minutes | Standard Deviation 0.25 |