MedTrace Logo

Efficacy, Safety and Efficiency of the nMARQ Pulmonary Vein Isolation System in Paroxysmal Atrial Fibrillation

NCT02268539 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2020-12-22

No results posted yet for this study

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 is a common condition which causes a fast and erratic heartbeat. There are estimated to be 50,000 new cases diagnosed per year in the UK. The fast heart beat can cause symptoms such as palpitations, lightheadedness, chest pains, shortness of breath and fatigue.

Catheter ablation is a technique used for the control of AF. In this procedure a catheter (a long thin wire) is passed into the chambers of the heart via a large blood vessel in a leg. The tip of the catheter can destroy tiny sections of heart tissue that may be the source or trigger of the abnormal electrical impulses. One of the challenges of AF ablation is to maximize success rates, as such there is currently rapid advances in technology to carry out this procedure.

Different catheters exist which deliver this energy in different ways. This study uses one such system to perform this procedure. It is called the nMARQ system for Pulmonary Vein Isolation produced by Biosense Webster. Currently this system is used in practice in the UK for patients with this medical condition.

What we seek to research is when ablating what is the optimum setting to perform ablation at. There is currently no data to guide best clinical practice in this area.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

ablation

Ablation ranging from 20-25 watts / 30-45 seconds

Sponsors & Collaborators

  • Anglia Ruskin University

    collaborator OTHER

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Stuart Tan, MB BC, MRCP · Mid and South Essex NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-01
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02268539 on ClinicalTrials.gov