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

NCT02268539 | Completed

• 1 other identifier: B703
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 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

Keywords

pilot study; atrial fibrillation; ablation; implanted loop recorder

Outcome Measures

Primary Outcomes (1)

• Efficacy; freedom from AF at 12 months

  One year success is defined as freedom from AF/AFL/AT off antiarrhythmic drug therapy as assessed from the end of the 3-month blanking period to 12 months following the ablation procedure in the intention to treat (ITT) population as randomized (based on ILR data)

  One year success

Secondary Outcomes (1)

• Safety

  7 days

Study Arms (4)

Ablation at 20 watt / 30 seconds

ACTIVE COMPARATOR

Participants randomised to 20 watt ablation for 30 seconds

Procedure: ablation

Ablation at 20 watt /45 seconds

ACTIVE COMPARATOR

20 watt ablation for 45 seconds

Procedure: ablation

Ablation at 25 watt / 30 seconds

ACTIVE COMPARATOR

25 watt ablation for 30 seconds

Procedure: ablation

iAblation at 25 watt / 45 seconds

ACTIVE COMPARATOR

25 watt ablation for 45 seconds

Procedure: ablation

Interventions

ablation PROCEDURE

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

Ablation at 20 watt / 30 seconds; Ablation at 20 watt /45 seconds; Ablation at 25 watt / 30 seconds; iAblation at 25 watt / 45 seconds

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Symptomatic Paroxysmal Atrial Fibrillation
• Drug refractory to one or more antiarrhythmic medication
• st Procedure for Patients
• LA \<5.5cm (TTE)

You may not qualify if:

• 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

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

The Essex Cardiothoracic Centre

Basildon, Essex, SS16 5NL, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stuart Tan, MB BC, MRCP

  Mid and South Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: October 20, 2014
• Study Start: February 1, 2014
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)