Model Based Fast Anatomical Mapping (MFAM)

Vivek Reddy

Status: Terminated

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation

Treatments: Device: MFAM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03349476

17-02-329

Details and patient eligibility

About

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.

Full 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

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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109 participants in 1 patient group

MFAM

Experimental group

Description:

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.

Treatment:

Device: MFAM