An interventional study of Hybrid Ablation and Catheter Ablation in Atrial Fibrillation, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-16.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
Atrial fibrillation (AF) is the most common cardiac arrhythmia with a lifetime risk of developing AF of 1 in 4 people aged over 40. Besides hemodynamic compromises stroke remains the most feared complication of AF with an increase in risk by 5-fold.
Catheter ablation has evolved as a standardized treatment option in paroxysmal AF. Due to the advanced electrical and structural remodeling the single procedural results of catheter ablation for persistent and longstanding persistent AF are rather disappointing without a proven superiority of any applied strategy compared to others. However, repeated catheter ablation can achieve better results. The surgical (epicardial) approach seems to be more effective, though still a significant amount of failures exist. Checking the epicardial ablation lines and if necessary making additional endocardial lines (which is a hybrid ablation) is expected to be most efficacious in avoiding lesion gaps and providing the most complete lesion set.
The study objective of this pilot trial is to compare the safety and efficacy of catheter ablation within 6 months versus a hybrid ablation consisting of endoscopic epicardial surgery combined with endocardial catheter ablation (performed one-stage) in preventing the recurrence of atrial fibrillation (AF) in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 41 is below the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epicardial surgical ablation performed thoracoscopically with occlusion/removal of the LAA combined with percutaneous endocardial ablation (one-stage).
Procedure: Hybrid Ablation
Percutaneous endocardial catheter ablation, with optional repeated catheter ablation(s).
Procedure: Catheter Ablation
The procedure will be performed following standard of care guidelines.
The procedure will be performed following standard of care guidelines.
Freedom from any AT off antiarrhythmic drugs class I or III lasting > 5 minutes after the blanking period, evaluated by any ECG-tracing and 7-day holter.
Time frame: 12 Months
Major complications during follow-up
Time frame: 12 Months
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center