Abstract
BackgroundSuccess rates with conventional transvenous endocardial pulmonary vein isolation in patients with persistent and longstanding persistent atrial fibrillation (AF) are variable due to advanced electrical and structural remodeling of the atria. As a consequence, more extensive endocardial lesions, minimally invasive thoracoscopic surgical techniques, and hybrid ablation (combining thoracoscopic epicardial surgical and endocardial catheter ablation) have been developed.HypothesisThe HARTCAP-AF trial hypothesizes that hybrid AF ablation is more effective than (repeated) transvenous endocardial catheter ablation in (longstanding) persistent AF, without increasing the number of associated major adverse events.MethodsThis randomized controlled trial will include 40 patients with persistent or longstanding persistent AF who will be 1:1 randomized to either hybrid ablation or (repeated) catheter ablation. The procedures and follow-up are conducted according to the guidelines. The primary effectiveness endpoint is freedom from any supraventricular arrhythmia lasting longer than 5 min without the use of Vaughan-Williams class I or III antiarrhythmic drugs through 12 months of follow-up after the last procedure. In the catheter ablation arm, a second procedure planned within 6 months after the index procedure is allowed for obtaining the primary endpoint. Additionally, adverse events, cost-effectiveness, and quality of life data will be recorded.Trial registrationClinicalTrials.gov, NCT02441738. Registered on 12 May 2015.
Highlights
Success rates with conventional transvenous endocardial pulmonary vein isolation in patients with persistent and longstanding persistent atrial fibrillation (AF) are variable due to advanced electrical and structural remodeling of the atria
While the addition of complex fractionated atrial electrograms (CFAE) ablation to pulmonary vein isolation (PVI) improved outcome in the STAR-AF I trial (74% vs. 48%, p = 0.004), neither the STAR-AF II trial (59% vs. 49%, p = 0.15) nor a large meta-analysis of 1415 patients
The stepwise approach consisting of PVI followed by disconnection of caval veins, CFAE ablation, and linear ablation of the roof and mitral isthmus until sinus rhythm is restored showed inconsistent results [11,12,13,14,15, 34]
Summary
Design and hypothesis This is a prospective, randomized trial conducted at the Maastricht University Medical Centre, Maastricht, the Netherlands. This study hypothesizes that a one-stage hybrid ablation will have greater clinical effectiveness during long-term follow-up compared with (repeated) endocardial catheter ablation in patients with (longstanding) persistent AF, without increasing the number of associated major adverse events. Randomization Randomization will be performed directly after written informed consent is obtained by the Clinical Trial Center Maastricht using the ALEA software program (FormsVision BV, Abcoude, the Netherlands) This software is programmed to distribute the number of patients over the two groups so that an even number of patients are treated with either catheter or hybrid ablation. If written informed consent is obtained, the patient is enrolled in the trial and randomized to one of the treatment arms Both the ablation strategies studied are currently accepted and recognized in the guidelines [19, 20, 24, 32]. A clinical research monitor of the Clinical Trial Center Maastricht regularly monitors the conduct of the study
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