Atrial FibrillationGOLD-FORCENCT02463851
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
A study testing PVAC GOLD multielectrode catheter and Contact Force single-tip ablation catheter in people with Atrial Fibrillation, run by L.V.A. Boersma at 3 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- PVAC GOLD multielectrode catheter and Contact Force single-tip ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2015to 1 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Netherlands2 sites
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, Utrecht, 3534CM
Isala Klinieken
Zwolle, 8011JW
About this study
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.
- Conditions
- Atrial Fibrillation
- Being tested
- PVAC GOLD multielectrode catheter, Contact Force single-tip ablation catheter
- Keywords
- Ablation, Multi-electrode catheter PVAC, Single-tip catheter Contact Force, Holter
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PVAC GOLD multielectrode catheterDevice
Cardiac ablation for Atrial Fibrillation
Contact Force single-tip ablation catheterDevice
| Study group | Role | What they receive |
|---|---|---|
| AF-Ablation with Multi-electrode catheter | Active comparator | Regular AF-ablation with a multi-electrode ablation catheter Receives: 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 Receives: Device: Contact Force single-tip ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
Measured: Month 3 after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startJun 2015
- Primary completion1 Apr 2021
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.V.A. Boersma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, L.V.A. Boersma, R&D Cardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463851
- Sponsor's protocol ID
- RDC-2014.01
- Acronym
- GOLD-FORCE
- Status last verified
- Sep 2021
- First submitted
- 2 Jun 2015
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02463851
- Acronym / sponsor ID
- GOLD-FORCE / RDC-2014.01
- Conditions
- Atrial Fibrillation
- Keywords
- Ablation, Multi-electrode catheter PVAC, Single-tip catheter Contact Force, Holter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- L.V.A. BoersmaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 4 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF-Ablation with Multi-electrode catheter | Active comparator | Device: PVAC GOLD multielectrode catheterRegular AF-ablation with a multi-electrode ablation catheter |
| AF-Ablation with Contact Force single-tip electrode | Active comparator | Device: Contact Force single-tip ablation catheterRegular AF-ablation with a regular Contact Force single-tip ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of symptomatic paroxysmal atrial fibrillation defined as:
- Age between 18 and 70 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
Key exclusion criteria (15 listed)
- Structural heart disease of clinical significance including:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PVAC GOLD multielectrode catheterCardiac ablation for Atrial Fibrillation | Device | AF-Ablation with Multi-electrode catheter |
| Contact Force single-tip ablation catheter | Device | AF-Ablation with Contact Force single-tip electrode |
Primary outcome
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
Time frame: Month 3 after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PVAC GOLD multielectrode catheter and Contact Force single-tip ablation catheter in people with Atrial Fibrillation, run by L.V.A. Boersma at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs (time frame: Month 3 after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2021.