Atrial Fibrillation, Persistent and Longstanding Persistent Atrial Fibrillation
Conditions
Keywords
Atrial Fibrillation, Persistent and Longstanding Persistent AF, Hybrid Procedure, Catheter Ablation
Brief summary
This is a prospective, randomized (2:1) multicenter trial to investigate the optimal treatment of Persistent and Longstanding Persistent AF referred for Radiofrequency (RF) ablation.The study objective is to compare the efficacy and safety of two interventional approaches, in preventing the recurrence of AF in symptomatic, drug refractory patients with persistent or longstanding persistent atrial fibrillation.
Interventions
DEVICEAtriCure Bipolar System
DEVICEStandard Endocardial Ablation with Catheter
DEVICEAtriClip® PRO LAA Exclusion System
DEVICEEndocardial Ablation with Catheter
DEVICERepeated Endocardial ablation(s)
Sponsors
Cardialysis BV
AtriCure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient has a history of symptomatic Persistent AF and a left atrium (LA) \> 4cm or Long Standing Persistent AF as defined by the HRS/EHRA/ECAS expert consensus statement 2. Patient is refractory to or intolerant of at least one antiarrhythmic drug (class I or III) 3. Patient is mentally able and willing to give informed consent
Exclusion criteria
1. Patient has longstanding persistent AF \> 10 years 2. Patient presenting with paroxysmal AF 3. Patient with persistent AF and a LA-diameter ≤ 4cm 4. AF is secondary to electrolyte imbalance, thyroid disease, or other reversible or non-cardiovascular cause 5. Patient underwent previous ablation procedure or heart surgery 6. Patient needs other cardiac surgery procedures besides AF treatment (valve, coronary, others) 7. Contraindication for either catheter ablation or epicardial surgery (including, but not limited to: previous thoracic radiation, previous perimyocarditis, Previous cardiac tamponade, Pleural adhesions, Prior thoracotomy) 8. Body mass index \> 35 9. LA Diameter \> 6 cm 10. Left ventricular ejection fraction \< 30 % 11. Severe mitral regurgitation (\>II) 12. Patient unable to undergo TransEsophageal Echocardiogram (TEE) 13. Presence of LA thrombus by TEE, CT scan, MRI or angiography 14. History of cerebrovascular disease, including stroke or transient ischemic attack (TIA) within 6 months prior to enrollment 15. Active infection or sepsis 16. Other clinical conditions precluding inclusion (e.g., organ disease, disturbances of hemostasis) 17. Contraindication to anticoagulant therapy, or inability to comply with anticoagulant therapy 18. Pregnancy, planned pregnancy or breastfeeding 19. Life expectancy is less than 12 months 20. Patient is involved in another study involving an investigational drug or device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects free from documented Atrial Fibrillation (AF), Atrial Flutter (AFL) or Atrial Tachycardia (AT) episodes > 30 seconds in duration through 12 months follow-up, in the absence of Class I or III Antiarrhythmic Drugs (AADs). | Through 12-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) |
Secondary
| Measure | Time frame |
|---|---|
| Number of subjects free from documented AF, AFL or AT episodes > 30 seconds in duration through 24 and 36 months follow-up, in the absence of Class I or III AADs. | Through 24- and 36-months post the Endocardial procedure (Hybrid Procedure) or last allowed Catheter Ablation(Catheter Procedure) |
Other
| Measure | Time frame |
|---|---|
| Composite major complications | Up to 180 days (6-months) post index procedure |
Countries
Czechia, Germany, Netherlands, Poland, United Kingdom
Outcome results
None listed