Efficacy, Safety and Efficiency of the nMARQ Pulmonary Vein Isolation System in the Treatment of Paroxysmal Atrial Fibrillation - A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Efficacy; freedom from AF at 12 months
Study Overview
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.
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 month prior to the ablation procedure, an Implanted Loop Recorder (ILR) (the REVEAL XT) will be implanted into the patient for robust, continuous, long term monitoring of the burden of arrhythmia following the case.
It has been decided to use continuous implanted rhythm monitors to allow for robust complete data capture of arrhythmia recurrence and burden with little impact to the patient after implantation. These are increasingly being used in the follow up of patients undergoing AF ablation. They give a continuous data feed showing the presence and quantity of abnormal rhythm seen after ablation. Their use has been approved in the follow up of AF ablation procedures within recent consensus guidelines formulated by the American College of Cardiology, the American Heart Association, the European Cardiac Arrhythmia Society, the European Heart Rhythm Association, the Society of Thoracic Surgeons, and the Heart Rhythm Society. There are several papers showing the validation of data collected by the REVEAL XT ILR and the benefit of continuous monitoring versus conventional methods of intermittent ambulatory ECGs.
The settings chosen for ablation are guided both by preclinical data collected by Biosense Webster and also the settings being used clinically worldwide when utilising this system. It has been decided to have a two by two study design varying the wattages 20W and 25W and also varying the time periods per lesion 20 seconds and 40 seconds.
We feel that this project can be carried out as a pilot study to potentially inform further research. There is very little clinical data published on how best to use of this device. At present it is left to individual clinicians to form their own "best practise" when choosing ablation settings. We seek to formalise the potential ablation variables into a structured format that will allow for comparisons to be drawn at the end of the study and to form the basis of future research.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Ablation at 20 watt /45 seconds
20 watt ablation for 45 seconds
Intervention: ablation (Procedure)
Ablation at 20 watt / 30 seconds
Participants randomised to 20 watt ablation for 30 seconds
Intervention: ablation (Procedure)
Ablation at 25 watt / 30 seconds
25 watt ablation for 30 seconds
Intervention: ablation (Procedure)
iAblation at 25 watt / 45 seconds
25 watt ablation for 45 seconds
Intervention: ablation (Procedure)
Outcomes
Primary Outcomes
Efficacy; freedom from AF at 12 months
Time Frame: One year success
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)
Secondary Outcomes
- Safety(7 days)