NCT02463851

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

5.8 years

First QC Date

June 2, 2015

Last Update Submit

September 17, 2021

Conditions

Atrial Fibrillation

Keywords

AblationMulti-electrode catheter PVACSingle-tip catheter Contact ForceHolter

Outcome Measures

Primary Outcomes (1)

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

    Month 3 after intervention

Study Arms (2)

AF-Ablation with Multi-electrode catheter

ACTIVE COMPARATOR

Regular AF-ablation with a multi-electrode ablation catheter

Device: PVAC GOLD multielectrode catheter

AF-Ablation with Contact Force single-tip electrode

ACTIVE COMPARATOR

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

Device: Contact Force single-tip ablation catheter

Interventions

PVAC GOLD multielectrode catheterDEVICE

Cardiac ablation for Atrial Fibrillation

AF-Ablation with Multi-electrode catheter
Contact Force single-tip ablation catheterDEVICE
AF-Ablation with Contact Force single-tip electrode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Praxisklinik Herz und Gefäße

Dresden, D-01099, Germany

Location

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Utrecht, 3534CM, Netherlands

Location

Isala Klinieken

Zwolle, 8011JW, Netherlands

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

June 2, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

September 23, 2021

Record last verified: 2021-09

Locations

NL(2)DE(1)