NCT03349476

Model Based Fast Anatomical Mapping

Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 109 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Paroxysmal Atrial Fibrillation
• Persistent Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	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

Timeline

• Start date: 2018-04-16
• Primary completion: 2022-10-03
• Completion: 2022-10-03
• First posted: 2017-11-21
• Last updated: 2023-11-29
• Results posted: 2023-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study