Back to resultsPVAC 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)
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
PVAC GOLD multielectrode catheter
Contact Force single-tip ablation catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring Ablation, Multi-electrode catheter PVAC, Single-tip catheter Contact Force, Holter
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
- Praxisklinik Herz und Gefäße
- St. Antonius Ziekenhuis Nieuwegein
- Isala Klinieken
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
AF-Ablation with Multi-electrode catheter
AF-Ablation with Contact Force single-tip electrode
Arm Description
Regular AF-ablation with a multi-electrode ablation catheter
Regular AF-ablation with a regular Contact Force single-tip ablation catheter
Outcomes
Primary Outcome Measures
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02463851
Brief 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
Acronym
GOLD-FORCE
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
L.V.A. Boersma
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Ablation, Multi-electrode catheter PVAC, Single-tip catheter Contact Force, Holter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AF-Ablation with Multi-electrode catheter
Arm Type
Active Comparator
Arm Description
Regular AF-ablation with a multi-electrode ablation catheter
Arm Title
AF-Ablation with Contact Force single-tip electrode
Arm Type
Active Comparator
Arm Description
Regular AF-ablation with a regular Contact Force single-tip ablation catheter
Intervention Type
Device
Intervention Name(s)
PVAC GOLD multielectrode catheter
Intervention Description
Cardiac ablation for Atrial Fibrillation
Intervention Type
Device
Intervention Name(s)
Contact Force single-tip ablation catheter
Primary Outcome Measure Information:
Title
Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs
Time Frame
Month 3 after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Praxisklinik Herz und Gefäße
City
Dresden
ZIP/Postal Code
D-01099
Country
Germany
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3534CM
Country
Netherlands
Facility Name
Isala Klinieken
City
Zwolle
ZIP/Postal Code
8011JW
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
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
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