Clinical trial NCT02463851: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Ablation
Multi-electrode catheter PVAC
Single-tip catheter Contact Force
Holter
Lead sponsor: R&D Cardiologie
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. 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
2. 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:

1. 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
2. Prior ablation for arrhythmias other than AF within the past three months
3. Prior left sided AF ablation
4. 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

Primary outcomes:
measure: Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
timeFrame: Month 3 after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Praxisklinik Herz und Gefäße
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
state: Utrecht
city: Zwolle
country: Netherlands
facility: Isala Klinieken
Study officials:
References: