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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Praxisklinik Herz und Gefäße, Dresden, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PVAC GOLD multielectrode catheter

Device

Cardiac ablation for Atrial Fibrillation

Contact Force single-tip ablation catheter

Device

Primary outcomes

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

Time frame: Month 3 after intervention

Sponsors and collaborators

Lead sponsor

L.V.A. Boersma

Other

Registry information

Acronym: GOLD-FORCE

Important dates

Study start: 2015
Primary completion: 2021
Study completion: 2021
First posted: Jun 4, 2015
Registry last updated: Sep 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed