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CompletedNCT02463851GOLD-FORCEUpdated Sep 23, 2021

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

An interventional study of PVAC GOLD multielectrode catheter and Contact Force single-tip ablation catheter in Atrial Fibrillation, sponsored by L.V.A. Boersma. Completed at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-23.

Sponsored by L.V.A. Boersma · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Atrial Fibrillation

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Keywords

  • Ablation
  • Multi-electrode catheter PVAC
  • Single-tip catheter Contact Force
  • Holter
03

In context

Atrial Fibrillation

3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.

This study's enrollment of 212 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.

Browse Atrial Fibrillation studies →

Lead sponsor

L.V.A. Boersma is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
212 participants (actual)

Study arms

  • Active comparator
    AF-Ablation with Multi-electrode catheter

    Regular AF-ablation with a multi-electrode ablation catheter

    Device: PVAC GOLD multielectrode catheter

  • Active comparator
    AF-Ablation with Contact Force single-tip electrode

    Regular AF-ablation with a regular Contact Force single-tip ablation catheter

    Device: Contact Force single-tip ablation catheter

Interventions

  • DevicePVAC GOLD multielectrode catheter

    Cardiac ablation for Atrial Fibrillation

  • DeviceContact Force single-tip ablation catheter
06

What researchers measure

Primary outcomes

  1. Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs

    Time frame: Month 3 after intervention

07

Study locations

3 sites
  • Praxisklinik Herz und Gefäße
    Dresden, D-01099, Germany
  • St. Antonius Ziekenhuis Nieuwegein
    Nieuwegein, Utrecht 3534CM, Netherlands
  • Isala Klinieken
    Zwolle, 8011JW, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02463851
Lead sponsor
L.V.A. Boersma
Responsible party
L.V.A. Boersma (Cardiologist, R&D Cardiologie) — Sponsor-investigator
First posted
Jun 4, 2015
Start date
Jun 2015
Primary completion
Apr 1, 2021
Completion
Apr 1, 2021
Last update
Sep 23, 2021

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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