PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The GOLD FORCE trial investigates the differences between treatment with a Contact Force single-tip catheter against the PVAC GOLD multielectrode catheter in cardiac ablation procedures in patients with paroxysmal atrial fibrillation.

Official Title
-----------------
PVAC GOLD Versus Irrigated RF Single Tip Catheter With Contact FORCE Ablation of the Pulmonary Veins for Treatment of Drug Refractory Symptomatic Paroxysmal and Persistent Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: PVAC GOLD multielectrode catheter
* Device: Contact Force single-tip ablation catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of symptomatic paroxysmal atrial fibrillation defined as: Self-terminating AF with episodes lasting no more than seven consecutive days before spontaneous conversion back to sinus rhythm Documentation of one or more events with PAF tracings by ECG, event recordings, pacemaker strips or monitor rhythm strips within the past year AF symptoms defined as the manifestation of any of the following: Palpitations Fatigue Exertional dyspnea Effort intolerance Age between 18 and 70 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study Exclusion Criteria: Structural heart disease of clinical significance including: Previous cardiac surgery (excluding CABG) Symptoms of congestive heart failure including, but not limited to, NYHA Class III or IV CHF and/or documented ejection fraction < 40% measured by acceptable cardiac testing Left atrial diameter of > 45mm as measured in the parasternal long axis on transthoracic echocardiogram LA volume>40 ml/m2 Stable/unstable angina or ongoing myocardial ischemia Myocardial infarction (MI) within three months of enrollment Aortic or mitral valve disease > Grade II Congenital heart disease (not including ASD or PFO without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure Prior ASD or PFO closure with a device using a percutaneous approach Hypertrophic cardiomyopathy (LV wall thickness > 1.5 cm) Pulmonary hypertension (mean or systolic PA pressure >50mm Hg on Doppler echo Prior ablation for arrhythmias other than AF within the past three months Prior left sided AF ablation Enrollment in any other ongoing arrhythmia study protocol Any ventricular tachy-arrhythmias currently being treated where the arrhythmia or the management may interfere with this study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AF-Ablation with Multi-electrode catheter<br>Regular AF-ablation with a multi-electrode ablation catheter | Device: PVAC GOLD multielectrode catheter<br>* Cardiac ablation for Atrial Fibrillation<br>|
| Active Comparator: AF-Ablation with Contact Force single-tip electrode<br>Regular AF-ablation with a regular Contact Force single-tip ablation catheter | Device: Contact Force single-tip ablation catheter<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs |  | Month 3 after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ablation, Multi-electrode catheter PVAC, Single-tip catheter Contact Force, Holter