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

Atrial Fibrillation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02463851
• Other study ID #: RDC-2014.01
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: April 1, 2021

Study information

• Verified date: September 2021
• Source: R&D Cardiologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• PVAC GOLD multielectrode catheter
Cardiac ablation for Atrial Fibrillation
• Contact Force single-tip ablation catheter

Locations

Country	Name	City	State
Germany	Praxisklinik Herz und Gefäße	Dresden
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein	Utrecht
Netherlands	Isala Klinieken	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
L.V.A. Boersma

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants free of Atrial Fibrillation and not taking anti-arrhythmic drugs		Month 3 after intervention