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
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 endoc...
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| Format: | Article |
| Language: | English |
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BMC
2019-06-01
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| Series: | Trials |
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| Online Access: | http://link.springer.com/article/10.1186/s13063-019-3365-9 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Mindy Vroomen |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-20T10:34:50Z |
| format | Article |
| id | doaj.art-f1a02903f2ef4adabafa3500bb8c0403 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-20T10:34:50Z |
| publishDate | 2019-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-f1a02903f2ef4adabafa3500bb8c04032022-12-21T19:43:39ZengBMCTrials1745-62152019-06-0120111110.1186/s13063-019-3365-9Hybrid thoracoscopic surgical and transvenous catheter ablation versus transvenous catheter ablation in persistent and longstanding persistent atrial fibrillation (HARTCAP-AF): study protocol for a randomized trialMindy Vroomen0Mark La Meir1Bart Maesen2Justin G. L. Luermans3Kevin Vernooy4Brigitte Essers5Bianca T. A. de Greef6Jos G. Maessen7Harry J. Crijns8Laurent Pison9Department of Cardiology, Maastricht University Medical CentreDepartment of Cardiothoracic Surgery, Maastricht University Medical CenterDepartment of Cardiothoracic Surgery, Maastricht University Medical CenterDepartment of Cardiology, Maastricht University Medical CentreDepartment of Cardiology, Maastricht University Medical CentreDepartment of Clinical Epidemiology and Medical Technology AssessmentDepartment of Clinical Epidemiology and Medical Technology AssessmentDepartment of Cardiothoracic Surgery, Maastricht University Medical CenterDepartment of Cardiology, Maastricht University Medical CentreDepartment of Cardiology, Maastricht University Medical CentreAbstract 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.http://link.springer.com/article/10.1186/s13063-019-3365-9Atrial fibrillationPersistentLongstanding persistentHybrid ablationCatheter ablation |
| spellingShingle | 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 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 Trials Atrial fibrillation Persistent Longstanding persistent Hybrid ablation Catheter ablation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Atrial fibrillation Persistent Longstanding persistent Hybrid ablation Catheter ablation |
| url | http://link.springer.com/article/10.1186/s13063-019-3365-9 |
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