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

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 - GOLD-FORCE

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON47914

Enrollment

200

Registered

2015-03-06

Start date

2015-06-04

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

paroxysmal atrial fibrillation

Interventions

Group 1: PVI ablation using PVAC GOLD catheter Group 2: PVI ablation using irrigated Single Tip catheter

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Symptomatic Atril Fibrillation, refractory to anti-arrhythmic drugs, with a guideline indication for ablation

Exclusion criteria

Exclusion criteria: prior ablation, dilated atria, prior stroke, significant structural disease requiring invasive treatment, valvular repair/replacement

Design outcomes

Primary

Measure	Time frame
Effectiveness: Freedom of AF during 1 yr follow-up Burden of AF Safety: Serious Adverse Events during 30 days post-procedure	—

Secondary

Measure	Time frame
Effectiveness: Symptom reduction, procedure times, findings during redo procedure Safety: Serious adverse events during 1 yr follow-up	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)