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

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Contact Force single-tip ablation catheter; Device: PVAC GOLD multielectrode catheter

• Registration Number: NCT02463851
• Lead Sponsor: L.V.A. Boersma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-02
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-04
• Primary Completion: 2021-04-01
• Study Completion: 2021-04-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-17
• Last Update Posted: 2021-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 212

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AF-Ablation with Contact Force single-tip electrode	Contact Force single-tip ablation catheter	Regular AF-ablation with a regular Contact Force single-tip ablation catheter
AF-Ablation with Multi-electrode catheter	PVAC GOLD multielectrode catheter	Regular AF-ablation with a multi-electrode ablation catheter

Primary Outcome Measures

Name	Time	Method
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs	Month 3 after intervention

Trial Locations

Locations (3)

Isala Klinieken; 🇳🇱 Zwolle, Netherlands

St. Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Utrecht, Netherlands

Praxisklinik Herz und Gefäße; 🇩🇪 Dresden, Germany