Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trial

Mindy Vroomen, Mark La Meir, Bart Maesen, Justin G L Luermans, Kevin Vernooy, Brigitte Essers, Bianca T A de Greef, Jos G Maessen, Harry J Crijns, Laurent Pison, Mindy Vroomen, Mark La Meir, Bart Maesen, Justin G L Luermans, Kevin Vernooy, Brigitte Essers, Bianca T A de Greef, Jos G Maessen, Harry J Crijns, Laurent Pison

Abstract

Background: 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. 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.

Hypothesis: The 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.

Methods: This 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 registration: ClinicalTrials.gov, NCT02441738 . Registered on 12 May 2015.

Keywords: Atrial fibrillation; Catheter ablation; Hybrid ablation; Longstanding persistent; Persistent.

Conflict of interest statement

MLM is a consultant for Atricure. The remaining authors declare that they have no competing interests

Figures

Fig. 1
Fig. 1
Box lesion in the setting of catheter ablation. Carto image showing a view of the posterior wall of the left atrium after wide area circumferential ablation of the pulmonary veins, and a connecting roof and inferior line (pink and red dots)
Fig. 2
Fig. 2
Intraoperative images of hybrid ablation. Left panel: left-sided thoracoscopic view of ablation of the left pulmonary veins using a bipolar clamp. Right panel: voltage map (Carto) after completion of the epicardial box lesion showing an isolated posterior left atrial wall. LAA left atrial appendix, PV pulmonary vein
Fig. 3
Fig. 3
Study flow chart. *A decision for a second ablation > 6 months after the index procedure, and a third ablation at any time are considered a failure. **A second procedure is always considered a failure. The primary endpoint is set at 12 months after the predefined ablation procedure(s). QOL quality of life
Fig. 4
Fig. 4
SPIRIT figure. CT computed tomography, ECG electrocardiogram

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