nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
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.
Lead Principal Investigator: J. Brian DeVille, MD
The Heart Hospital Baylor Plano
1100 Allied Drive
Plano, TX 75093
IRB Number: 013-080
| Condition | Atrial Fibrillation |
|---|---|
| Clinical Study Identifier | TX138013 |
| Last Modified on | 21 April 2022 |
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