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 (GOLD-FORCE)

September 17, 2021 updated by: L.V.A. Boersma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AF-Ablation with Multi-electrode catheter
Regular AF-ablation with a multi-electrode ablation catheter
Device: PVAC GOLD multielectrode catheter
Cardiac ablation for Atrial Fibrillation
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

L.V.A. Boersma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

April 1, 2021

Study Completion (Actual)

April 1, 2021

Study Registration Dates

First Submitted

June 2, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 4, 2015

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 17, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RDC-2014.01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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