Last updated on November 2017

nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation


Brief description of study

nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation

Detailed Study Description

The Main Study will consist of a prospective, multi-center, randomized (1:1 concurrent nMARQ™ Catheter System [nMARQ] vs THERMOCOOL® Navigational Family of catheters [TC]), controlled, two-arm, single-blind design. Embedded within the Main Study will be a Subpopulation Neurological Assessment (SNA) with a prospective, controlled design, with consecutive enrollment.

The objective of this study will be to demonstrate safety and effectiveness of nMARQ compared to TC in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).

The objective of the Subpopulation Neurological Assessment (SNA) is to evaluate the comparative incidence of symptomatic and asymptomatic cerebral emboli, and any associated neurological deficits, both pre- and post-ablation by treatment group, among a subset of Main Study subjects.

Clinical Study Identifier: TX81439

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