Clinical trial NCT03349476: Model Based Fast Anatomical Mapping
Official title: Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Persistent Atrial Fibrillation
Keywords: Atrial Fibrillation
AFIB
Ablation
Paroxysmal
Persistent
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Biosense Webster, Inc.
First posted: 2017-11-21
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: mMap Scoring Questionnaire
timeFrame: hospital discharge, average 24 hours post procedure
Secondary outcomes:
measure: Left Atrial Geometry Creation Time
timeFrame: during the procedure up to 60 minutes
measure: Fluoroscopy Time
timeFrame: hospital discharge, average 24 hours post procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mohit Turagam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Vivek Reddy, MD
role: STUDY_CHAIR
References: