Paroxysmal Atrial FibrillationMFAMNCT03349476
Model Based Fast Anatomical Mapping
A study testing MFAM in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paroxysmal Atrial Fibrillation, Persistent Atrial Fibrillation
- What is being tested?
- MFAM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2018to 3 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age ≥ 18 years
- Have AF as follows:
- Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting < 7 days.
- 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
Who cannot join
- Rheumatic heart disease,
- Current intra-cardiac thrombus
- Class IV HF
- Unable to sign consent
- Unstable angina
- Recent cerebral ischemic events
Show all 9Show fewer
- Contradiction to anticoagulation
- Prior cardiac surgery
- Complex congenital heart disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping
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.
Read the 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:
- Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
- Left atrial geometry creation time
- 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
- Being tested
- MFAM
- Keywords
- Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MFAMDevice
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
| Study group | Role | What they receive |
|---|---|---|
| MFAM | Experimental | 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. Receives: Device: MFAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: hospital discharge, average 24 hours post procedure
Secondary outcomes (2)
Left Atrial Geometry Creation Time
The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure
Measured: during the procedure up to 60 minutes
Fluoroscopy Time
Fluoroscopy (radiation) time for left atrial anatomy creation during the ablation procedure
Measured: hospital discharge, average 24 hours post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start16 Apr 2018
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Why it stopped: study closed prior to meeting enrollment goal due to difficulty enrolling.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vivek Reddy
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor-investigator, Vivek Reddy, Icahn School of Medicine at Mount Sinai
- Investigators
- Mohit Turagam, MD, Principal investigator, Icahn School of Medicine at Mount SinaiVivek Reddy, MD, Study chair, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349476
- Sponsor's protocol ID
- 17-02-329
- Acronym
- MFAM
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2017
- Last updated
- 29 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping
- ClinicalTrials.gov ID
- NCT03349476
- Acronym / sponsor ID
- MFAM / 17-02-329
- Keywords
- Atrial Fibrillation, AFIB, Ablation, Paroxysmal, Persistent
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study closed prior to meeting enrollment goal due to difficulty enrolling.
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Vivek ReddyUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 21 Nov 2017 (actual)
- Results
- Posted 27 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
- Left atrial geometry creation time
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MFAM | Experimental | Device: MFAMThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Have AF as follows:
- 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
Key exclusion criteria (9 listed)
- Rheumatic heart disease,
- Current intra-cardiac thrombus
- Class IV HF
- Unable to sign consent
- Unstable angina
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 |
|---|---|---|
| MFAMSpecifically, 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 | Device | MFAM |
Primary outcome
mMap Scoring Questionnaire
Time frame: 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)
2 secondary outcomes
Left Atrial Geometry Creation Time
Time frame: during the procedure up to 60 minutes
Fluoroscopy Time
Time frame: hospital discharge, average 24 hours post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Mohit Turagam, MD principal investigator
Icahn School of Medicine at Mount Sinai
Vivek Reddy, MD study chair
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MFAM in people with Paroxysmal Atrial Fibrillation and Persistent Atrial Fibrillation, run by Vivek Reddy at 1 site in United States.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 29 Nov 2023. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mMap Scoring Questionnaire (time frame: hospital discharge, average 24 hours post procedure). 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 29 Nov 2023.