Status:
COMPLETED
Efficacy, Safety and Efficiency of the nMARQ Pulmonary Vein Isolation System in Paroxysmal Atrial Fibrillation
Lead Sponsor:
Mid and South Essex NHS Foundation Trust
Collaborating Sponsors:
Anglia Ruskin University
Conditions:
Paroxysmal Atrial Fibrillation
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This is a pilot study designed to investigate the effectiveness of the nMARQ Pulmonary Vein Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different ablation settings. AF...
Detailed Description
This is a pilot study designed to investigate the use of the nMARQ Pulmonary Vein Isolation system in the treatment of Paroxysmal Atrial Fibrillation (AF) at different ablation settings. At least one...
Eligibility Criteria
Inclusion
- 18-80 years old
- Symptomatic Paroxysmal Atrial Fibrillation
- Drug refractory to one or more antiarrhythmic medication
- 1st Procedure for Patients
- LA \<5.5cm (TTE)
Exclusion
- LV EF \<30%
- Patient with correctable cause of AF
- Previous cardiac surgery
- History of previous CVA
- Pregnancy
- Smoke or LAA thrombus seen in LA on pre-procedural TOE
- Sub-therapeutic warfarinisation
- Contraindication to formal anticoagulation
- Life expectancy less than 365 days (12 months).
- Enrolment in an investigational study evaluating another device or drug
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02268539
Start Date
February 1 2014
End Date
December 31 2017
Last Update
December 22 2020
Active Locations (1)
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1
The Essex Cardiothoracic Centre
Basildon, Essex, United Kingdom, SS16 5NL