Combined Endoscopic Epicardial and Percutaneous Endocardial Ablation Versus Repeated Catheter Ablation in Persistent and Longstanding Persistent Atrial Fibrillation (CEASE-AF)

AtriCure

Status: Active, not recruiting

Conditions: Atrial Fibrillation; Persistent and Longstanding Persistent Atrial Fibrillation

Treatments: Device: AtriClip® PRO LAA Exclusion System; Device: Endocardial Ablation with Catheter; Device: Standard Endocardial Ablation with Catheter; Device: Repeated Endocardial ablation(s); Device: AtriCure Bipolar System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02695277

CP2015-1

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

Hybrid Procedure

Experimental group

Description:

Endoscopic epicardial surgical ablation (first stage) combined with endocardial catheter ablation (second stage) performed between 91 and 180 days post index procedure.

Treatment:

Device: AtriCure Bipolar System

Device: Endocardial Ablation with Catheter

Device: AtriClip® PRO LAA Exclusion System

Catheter Procedure

Active Comparator group

Description:

Standard catheter ablation with pulmonary vein (PV) isolation (minimum lesion set) and optional additional lesions (index procedure). When required due to AF recurrence, ablation may be repeated within 6 months after the index-procedure according to clinical indications and consistent with the Heart Rhythm Society (HRS)/European Heart Rhythm Association (EHRA)/European Cardiac Arrhythmia Society (ECAS) Consensus Statement

Treatment:

Device: Repeated Endocardial ablation(s)

Device: Standard Endocardial Ablation with Catheter