Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| AtriCure, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. However, it is not known which technique is preferable in a given patient population in terms of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques
Atrial Fibrillation is the most common cardiac arrhythmia, affecting millions of people around the world. It is a large burden on health care resources and may even lead to a shorter life expectancy. Drug treatment has been found insufficient and sometimes even hazardous to the pt. Traditionally, there was only one invasive approach available, being MAZE 3 procedure by means of full open chest cardiac surgery. This was a very invasive approach, limited to only a few skilled surgeons, with insufficient options to treat large pt volume.
With the discovery that AF often is initiated and maintained by electrical instability inside and around the Pulmonary Veins, catheter ablation is now a widely accepted early invasive strategy to cure AF. Success rates of 60% to 90% have been reported, depending on technique employed and the type of AF (Resp, chronic versus paroxysmal)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Catheter RF ablation with complete circumferential ablation around the right and PVs, and additional lines between the lower and upper PVs, and towards the mitral valve ring. |
|
| 2 | Active Comparator | Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheter Ablation | Procedure | RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from AF and/or secondary left atrial arrhythmias, lasting >60 sec, as determined by 7 day continuous Holter monitoring. | 6 months | |
| Safety and/or adverse events | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom of AADs, Decrease in the frequency and duration of AF episodes, Decrease in the number of AF related hospital admissions, Improvement in quality of life internet Follow Up, Decrease in number of cardioversions, PM implant | 6 and 12 Months | |
| Composite major complications, Serious Adverse Events, Serious Adverse Effects |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lucas Boersma, MD/PhD | St. Antonius Hospital | Principal Investigator |
| WimJan van Boven, MD | St. Antonius Hospital | Principal Investigator |
| Lluis Mont, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Castella M, MD | Hospital Clinic of Barcelona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Antonius Hospital Nieuwegein | Nieuwegein | 3430 | Netherlands | |||
| Hospital Clinic Barcelona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22082673 | Derived | Boersma LV, Castella M, van Boven W, Berruezo A, Yilmaz A, Nadal M, Sandoval E, Calvo N, Brugada J, Kelder J, Wijffels M, Mont L. Atrial fibrillation catheter ablation versus surgical ablation treatment (FAST): a 2-center randomized clinical trial. Circulation. 2012 Jan 3;125(1):23-30. doi: 10.1161/CIRCULATIONAHA.111.074047. Epub 2011 Nov 14. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| D017115 | Catheter Ablation |
| ID | Term |
|---|---|
| D000078703 | Radiofrequency Ablation |
| D000078702 | Radiofrequency Therapy |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Surgical Ablation | Procedure | Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA. |
|
| 12 Months |
| Barcelona |
| Spain |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 |
| Surgical Procedures, Operative |