reMARQable v3.1

• Research type

  Research Study

• Full title

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

• IRAS ID

  145819

• Contact name

  Ghulam André Ng

• Contact email

  gan1@le.ac.uk

• Clinicaltrials.gov Identifier

  NCT01824394

• Research summary

  The Main Study will consist of a prospective, multi-center, randomized(1:1 concurrent nMARQ™ technology 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. Main objective is to demonstrate safety and effectiveness of nMARQ™ technology [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
  

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  14/YH/0141

• Date of REC Opinion

  24 Jun 2014

• REC opinion

  Further Information Favourable Opinion